Warning Letters Issued To Sponsors, IRBs And Investigators .
Warning Letters Issued to Sponsors, IRBs and Investigators from 2010 to 2019ByDeepika Sri Prashanthi GundrathiResearch ProjectSubmitted to the School of Health SciencesEastern Michigan UniversityIn partial fulfillment of the requirements for the degree ofMASTER OF SCIENCEinClinical Research AdministrationSubmitted toIrwin Martin, Ph.D.13 March 2020Ypsilanti, Michigan
FDA Warning Letters 2010 to 2019AbstractThe Bioresearch Monitoring Program, administered by the Office of Scientific Investigations,ensures the integrity of safety and efficacy of clinical trial data that is submitted to the U.S. Foodand Drug Administration. Any objectionable findings discovered during an inspection may resultin a Warning Letter to the responsible organization. This study examined 91 Warning Lettersissued to sponsors, IRBs and investigators from 2010 to 2019 and compared these findings withthose of previous studies. The most critical observation made was the repetitive nature of thetypes of violations being cited to all three organizations, not only over the last decade but alsoprior to 2010. Findings also demonstrated an overall decrease in the number of Warning Lettersand violations cited between 2010 and 2019. Furthermore, the number of Warning Letters issuedto investigators during this time revealed a meaningful decrease from the previous decade.ii
FDA Warning Letters 2010 to 2019Table of ContentsAbstract .iiList of Tables .ivList of Figures .vIntroduction .1Office of Scientific Inspections (OSI) .1History of OSI .1Functions of OSI .3Bioresearch Monitoring Program (BIMO) .3What are Warning Letters? .4Form 483 .4Purpose of this Study .6Methods .7Results .8Sponsors.9IRBs .11Investigators .14Discussion .17Conclusion .22References .23iii
FDA Warning Letters 2010 to 2019List of TablesTable 1: Inspections & Warning Letters for Sponsors, IRBs and Investigators .8Table 2: Classification of Violations Issued to Sponsors .9Table 3: Number of Sponsor Violations During the Years 2010 to 2019 .10Table 4: Classification of Violations Issued to IRBs .11Table 5: Number of IRB Violations During the Years 2010 to 2019 .13Table 6: Classification of Violations Issued to Investigators .14Table 7: Number of Investigator Violations During the Years 2010 to 2019 .16iv
FDA Warning Letters 2010 to 2019List of FiguresFigure 1: Frequency of Top Three Violations Cited to IRBs .18Figure 2: Frequency of Top Three Violations Cited to Investigators .20v
FDA Warning Letters 2010 to 2019IntroductionThe most important element of clinical research is the quality of the clinical trials.Clinical trials are conducted to obtain the data required to assess the safety and efficacy of drugsin support of new drug approvals. It is thus important that clinical trials are conducted inaccordance with the principles of the Declaration of Helsinki (1964), which aims at protectingthe safety, rights and well-being of human subjects. Clinical trial sponsors, investigators, IRBsand monitors are required to comply with the International Conference on Harmonization GoodClinical Practice (ICH GCP), which is an international quality standard for the rights and safetyof human trial subjects, and following ICH GCP guidance ensures the quality, integrity andreliability of data collected (U.S. Food & Drug Administration, 2018c). The U.S. Food and DrugAdministration (FDA) conducts on-site inspections and data audits through the BioresearchMonitoring Program (BIMO) to oversee various aspects of a study. Violations of the 21 CFR 312(Investigational New Drug Application) regulations identified during BIMO inspections maygenerate Warning Letters to the responsible organizations.Office of Scientific Inspections (OSI)The Office of Scientific Inspections (OSI), which operates within the Office ofCompliance in the Center for Drug Evaluation and Research (CDER), is responsible for verifyingthe integrity of safety and efficacy data that is submitted to the FDA in support of new drugapplications and also for ensuring that the rights and safety of human participants in clinical trialsare protected (U.S. Food & Drug Administration, 2018e).History of OSI. The Federal Food, Drug, and Cosmetic (FDC) Act was passed by theU.S. Congress in 1938, for the first time requiring new drugs be proven safe (U.S. Food & Drug1
FDA Warning Letters 2010 to 2019Administration, 2014a). Thus, the results of testing on any new drugs would need to besubmitted to the FDA in a new drug application (NDA) before that drug could be marketed to thepublic. A few decades later in 1960, a new drug application was received by the FDA for asedative called thalidomide, which had been used for years in other countries to treat variousmaladies, including morning sickness in pregnant women. The William Merrell Company waskeen on bringing the drug to the U.S. market; however, FDA medical officer Frances OldhamKelsey denied the new drug application, citing insufficient safety data. Lacking an approved newdrug application, the company decided instead to distribute the drug for investigational use,effectively putting more than 2 million tablets of it into the hands of physicians and pharmacistsfor the treatment of their patients (U.S. Food & Drug Administration, 2014a).By 1962, the drug was being linked to severe birth defects in thousands of newborns inother countries, and the William Merrell Company had no choice but to recall the distributedtablets back from U.S. clinics and pharmacies. As a result, a 1960 bill to strengthen the drugprovisions of the FDC Act was reintroduced into Congress, becoming the Drug Amendment of1962 and that same year being signed into law by President John F. Kennedy. This law mandatedthat drug manufacturers submit efficacy as well as safety data to the FDA prior to marketing andthat all human subjects in clinical trials sign informed consent. Importantly, the law also gave theFDA the authority to regulate investigational use of unapproved new drugs (U.S. Food & DrugAdministration, 2014a).As a consequence of the new law, the Division of New Drugs was restructured, and Dr.Frances Kelsey was given direction of its Investigational Drug Branch, which was responsiblefor assessing how well proposed clinical trials comply with regulations on investigational drugs2
FDA Warning Letters 2010 to 2019and would eventually be reorganized and become today’s OSI (U.S. Food & DrugAdministration, 2014a).Functions of OSI. As mentioned previously, the OSI aims to ensure the rights and safetyof human trial participants as well as the quality of clinical research data submitted for new drugapprovals with the FDA (U.S. Food & Drug Administration, 2018d). All of this is done throughinspection of the organizations involved in research studies. Primarily, the OSI monitors researchinvestigators, sponsors, and IRBs to confirm that they are operating in accordance with federalregulations on good clinical practice and good laboratory practice. The OSI is charged withimplementing the Bioresearch Monitoring Program (BIMO) (U.S. Food & Drug Administration,2018d).Bioresearch Monitoring Program (BIMO)The Bioresearch Monitoring Program (BIMO) is an essential aspect of the FDA preapproval process for new medical drugs, biologics and devices, food and color additives, andveterinary products being considered for use among the general population in the United States(U.S. Food & Drug Administration, 2019c). It provides extensive guidelines for on-siteinspections and data audits for clinical research studies submitted to the FDA for the approval ofnew products. The BIMO Program supports more than 1000 inspections each year through itscompliance programs, of which this study will focus on the following three: Sponsors Institutional Review Board; and Clinical Investigators (U.S. Food & Drug Administration, 2019a).The BIMO Program guidelines not only aim to ensure the quality of reported dataregarding new products submitted for FDA approval, but also to assure that studies are done in3
FDA Warning Letters 2010 to 2019accordance with GCPs for the ethical and safe treatment of the human subjects who participate inFDA-regulated studies. When any organization—sponsor, investigator, or IRB—is found to be inmajor violation of a federal regulation, the OSI is responsible for issuing the appropriateWarning Letters and/or following up with further actions (U.S. Food & Drug Administration,2018d).What are Warning Letters?Major violations of one or more FDA regulations discovered during an inspection arereported to the responsible organization in the form of a Warning Letter. According to the FDA,a Warning Letter is defined as “an informal advisory to an organization communicating theAgency’s position on a matter but does not commit the FDA to taking enforcement action” (U.S.Food & Drug Administration, 2018c). Essentially, Warning Letters serve as a tool for postinspectional correspondence between the FDA and stakeholders (Talele & Bowalekar, 2012).Form 483. An FDA investigator issues a Form 483 to organization managementwhenever any conditions or conduct deemed objectionable is observed that may be in violationof the Food Drug and Cosmetic Act and/or related acts. All observations noted on Form 483 areto be clear, specific and significant to merit inclusion, and they must indicate that the safety orefficacy of a food, drug, device, or cosmetic has been compromised or is likely to becomecompromised as a direct result of how it is being prepared, packaged or stored (U.S. Drug &Food Administration, 2020b).According to the Information Sheet Guidance for IRBs, Clinical Investigators andSponsors (U.S. Drug & Food Administration, 2019d), after the completion of an FDA inspection,the inspector conducts an exit interview with the responsible organizations to discuss inspectionfindings. A response to the Form 483 may be given orally during the interview or in writing to4
FDA Warning Letters 2010 to 2019the FDA. The FDA inspector then prepares a written Establishment Inspection Report (EIR). TheEIR along with Form 483 (if applicable) and other documents collected during the inspection aresent to the FDA Center to evaluate and classify the inspection outcome. Upon this review, aWarning Letter will be issued if any major violations have been identified. If no objectionablefindings were noted during the inspection, a general letter may be issued indicating thenoncompliance observed; however, this letter is not always issued when the FDA does notobserve any significant violations. Additionally, in some cases, an informational or untitled lettermay be issued stating any deviation that does not meet the threshold to issue a Warning Letter. Awritten response will be requested in such cases.In the event of major objectionable conduct being observed, there are different types ofviolations that may be cited, and these are categorized based on the regulation being violated. Itis evident from previous studies that a few particular regulations have been repeatedly violatedover the years by IRBs, sponsors, and investigators (Shelley, 2004). For example, according toBramstedt and Kassimatis (2004), the most common violation cited to IRBs during the years1997 to 2004 was “failure to have and follow adequate written procedures on the way IRB wasconducting its review of research”. These findings were similar to those of a later studyconducted by Talele and Bowalekar (2012), who identified the same violation as being citedmost frequently during the years 2002 to 2009.Similarly, FDA inspections tend to uncover specific types of citations for sponsors, aswell. According to Shetty and Saiyed (2014), the most common violation cited for sponsorsduring the years 2011 to 2012 was the failure to follow the monitoring schedule. An example ofthis type of violation was cited to Oeyama Moto Medical Group Foundation in 2016, with theexplanation that there was a lack of monitoring records associated with the inspected study.5
FDA Warning Letters 2010 to 2019Failure to obtain investigator agreement was the second most common violation issued tosponsors during that period (Shetty & Saiyed, 2014).According to Bedadala (2014), the most common violation cited to investigators duringthe years 2002 to 2011 was failure to conduct the study according to investigational plan andconditions put forth by IRB. On the other hand, there was no significant trend observed in thenumber of Warning Letters issued to investigators over that same period (Bedadala, 2014). Thesestudies mentioned here sought to determine trends in the Warning Letters and violations issuedto one of the three organizations—either sponsors, investigators or IRBs—but did not considercomparing Warning Letter data across all three organizations. Moreover, because of the dates ofpublication for these studies, each lacks the inclusion of the most recent Warning Letter dataavailable. This study examined Warning Letters published on the FDA website from 2010 to2019 which were issued to sponsors, IRBs and investigators, and then compared the results withprevious studies to identify potential trends.Purpose of this StudyPrimary objective. To determine whether trends exist in the violations issued to clinicaltrial sponsors, IRBs or investigators during the years 2010 to 2019.Secondary Objectives. To identify the most common violations cited to clinical trialsponsors, IRBs and investigators during the years 2010 to 2019 and to identify the frequency ofcommonly cited violations.6
FDA Warning Letters 2010 to 2019MethodsThis study utilized the FDA Warning Letters archive as a data source of Warning Lettersissued to sponsors, IRBs and investigators between the years of 2011 and 2019. All WarningLetters are listed on the FDA Warning Letter index page by their year of issue (U.S. Food &Drug Administration, 2020d). These letters were searched manually based on the year of issueand then categorized for the purpose of this study. First, all Warning Letters were placed in threecategories for those issued to sponsors, IRBs and investigators, then within each category theWarning Letters were further divided based on their year of issue. Each Warning Letter wasreviewed thoroughly, and the citations in each letter were noted. A list of citations was preparedseparately for sponsors, IRBs and investigators. These citations were further categorized basedon the type of violation and regulation that was violated. Finally, trends in the number ofWarning Letters issued, violations cited over the 10-year period for each of the threeorganizations, and the most commonly cited violations and their frequencies were analyzed toobserve how they had evolved over the last decade.7
FDA Warning Letters 2010 to 2019ResultsThe OSI conducted inspections each year of sponsors, IRBs and investigators during theperiod of 2010-2019. Inspections of sponsors led to Warning Letter issuance 0-3.4% of the time.For IRBs, inspections resulted in a Warning Letter being issued as little as zero and as much as5.4% of the time, and anywhere from zero to 4.3% of inspections of investigators led to aWarning Letter. Annual numbers for inspections and Warning Letters, as well as the percentageof inspections resulting in a Warning Letter, are listed below (see Table 1). Data on inspectionsfor the year 2019 were not available at the time of this study; however, the FDA had publisheddata on the Warning Letters issued during that year.Table 1: Inspections & Warning Letters for Sponsors, IRBs and s ’s with 0%46911.2%45133.7%43200%52100%5470Total%WL’s With .1%851.2%1040.7%500%0238
FDA Warning Letters 2010 to 2019SponsorsIn total, 11 Warning Letters (WL’s) to sponsors were published on the FDA webpageduring the years 2010-2019. Twelve different types of violations (see Table 2) were cited tosponsors over this period. Of these 12 types of violations, “failure to ensure proper monitoring ofthe clinical investigations [21 CFR 312.50; 312.56(a)]” was the most common violation (seeTable 3). A description for each type of violation and the number of citations for that violationare provided below (see Tables 2 and 3).Table 2: Classification of Violations Issued to Sponsors.TypeDescriptionCode ofFederalRegulations21 CFR 312.50;312.56(a)1Failure to ensure proper monitoring of the clinical investigations2Failure to ensure that an investigation was conducted in accordancewith the general investigational plan and protocols as specified in the 21 CFR 312.50IND3Failure to secure investigator compliance with the investigationalplan and applicable FDA regulations21 CFR312.56(b)4Failure to ensure that only investigators who were qualified bytraining and experience were selected as appropriate experts toinvestigate a drug21 CFR312.53(a)5Failure to keep each participating investigator informed of newobservations discovered by or reported to the sponsor on the drug,particularly with respect to adverse effects and safe use21 CFR312.55(b)6Failure to comply with the requirements for use of an investigationalnew drug in a clinical investigation by administering the21 CFR 312.40investigational new drugs Compounds 1, 2, and 3 to subjects withoutan IND in effect7Failure to obtain prior written authorization from FDA prior tocharging for an investigational drug21 CFR312.8(a)(3)9
FDA Warning Letters 2010 to 20198Failure to maintain adequate records showing the receipt, shipmentor other disposition of an investigational drug21 CFR312.57(a)9Failure to obtain informed consent in accordance with the provisions21 CFR 312.60of 21 CFR part 50, as required by 21 CFR 312.6010Failure to ensure that an IRB complying with the requirements setforth in 21 clinical studies21 CFR 312.6611Failure to maintain adequate records of the disposition of the drug,including dates, quantity, and use by subjects21 CFR312.62(a)12Failure to obtain from an investigator sufficient financialinformation to allow the sponsor to submit complete and accuratecertification or disclosure statements required under 21 CFR part 5421 CFR312.53(c)(4)Table 3: Number of Sponsor Violations During the Years 2010 to 2019.Violation 201020112012 2013201420152016201720182019Type 10001220000Type 22001210000Type 30000000000Type 40000000000Type 51000000000Type 61000111100Type 71000000000Type 81000100000Type 91000000001Type 101000000000Type 111000000000Type 12T00100000010
FDA Warning Letters 2010 to 2019IRBsThe FDA published a total of 19 Warning Letters to IRBs on its webpage between 2010 and2019. Nineteen different types of violations (see Table 4) were cited to investigators over thisperiod, out of which “failure to prepare and maintain adequate documentation of IRB activities,including minutes of IRB meetings [21 CFR 56.115(a)(2)]” was the most common violation (seeTable 5). A description for each type of violation and the number of citations for that violationare provided below (see Tables 4 and 5).Table 4: Classification of Violations Issued to IRBs.TypeDescriptionCode ofFederalRegulations1Failure to follow its written procedures for conducting its initial andcontinuing review of research21 CFR56.108(a)(1)2Failure to conduct continuing review of research at intervals of not less 21 CFRthan once per year56.109(f)3Failure to prepare and maintain written procedures for the IRB andfailed to follow written procedures as required by 21 CFR 56.108(a)and (b)21 CFR56.115(a)(6)4Failure to prepare and maintain a list of IRB members identified byname; earned degrees; representative capacity; indications ofexperience sufficient to describe each member’s chief anticipatedcontributions to IRB deliberations; and any employment or otherrelationship between each member and the institution21 CFR56.115(a)(5)5Failure to review proposed research at convened meetings at which amajority of the members of the IRB are present, including at least onemember whose primary concerns are in nonscientific areas21 CFR56.108(c)6Failure to notify investigators and the institution in writing of itsdecision to approve or disapprove proposed research activities, or ofmodifications required to secure IRB approval of the research activity21 CFR56.109(e)7Failure to follow its written procedures for ensuring that changes inapproved research, during the period for which IRB approval hasalready been given, may not be initiated without IRB review and21 CFR56.108(a)(4)11
FDA Warning Letters 2010 to 2019approval except where necessary to eliminate apparent immediatehazards to the human subjects8Failure to determine that risks to subjects are minimized21 CFR56.111(a)(1)9Failure to follow FDA regulations regarding expedited reviewprocedures21 CFR56.110(b)10Failure to prepare and maintain adequate documentation of IRBactivities, including minutes of IRB meetings21 CFR56.115(a)(2)11Failure to ensure that information given to subjects as part of informedconsent is in accordance with 21 CFR Part 50.2521 CFR56.109(b)12Failure to ensure that no member participated in the initial orcontinuing review of a project in which the member had a conflictinginterest, except to provide information requested by the IRB21 CFR56.107(e)13Failure to demonstrate its ability to ascertain the acceptability of theproposed research in terms of institutional commitments, regulations,applicable law, and standards of professional conduct and practice21 CFR56.107(a)14Failure to determine at the time of initial review that studies involving21 CFRchildren are in compliance with 21 CFR Part 50, Subpart D, Additional56.109(h)Safeguards for Children in Clinical Investigations15Failure to prepare and maintain adequate documentation of IRBactivities, including copies of all research proposals reviewed,approved consent documents, and progress reports submitted byinvestigators21 CFR56.115(a)(1)16Failure to maintain copies of all correspondence between the IRB andinvestigators21 CFR56.115(a)(4)17Failure to ensure that informed consent would be sought from eachprospective subject or the subject’s legally authorized representative inaccordance with and to the extent required by 21 CFR Part 5021 CFR56.111(a)(4)18Failure to fulfill membership requirements21 CFR56.10719Approval of research without determining that risks to subjects werereasonable in relation to anticipated benefits, if any, to subjects, andthe importance of the knowledge that may be expected to result21 CFR56.111(a)(2)12
FDA Warning Letters 2010 to 2019Table 5: Number of IRB Violations During the Years 2010 to 2019.Violation 201020112012 2013201420152016201720182019Type 12220000000Type 21110001000Type 31053002000Type 41030000000Type 51031011000Type 61011001000Type 71000000000Type 81201000000Type 90221000000Type 100242012000Type 110201000000Type 120110000000Type 130100000000Type 140013010000Type 150020000000Type 160021000000Type 170010000000Type 180002000000Type 19000100000013
FDA Warning Letters 2010 to 2019InvestigatorsOverall, a total of 61 Warning Letters to investigators were issued and published by theFDA from 2010 to 2019. Twenty different types of violations (see Table 6) were cited tosponsors over this period. The most commonly cited violation was “failure to ensure that theinvestigation was conducted according to the investigational plan [21 CFR 312.60]” (see Table7). A description for each type of violation and the number of citations for that violation areprovided below (see Tables 6 and 7).Table 6: Classification of Violations Issued to Investigators.Code ofFederalRegulationsTypeDescription1Failure assure that an Institutional Review Board (IRB) thatcomplies with the requirements set forth in part 56 was responsiblefor the initial review and approval of Protocol (b)(4)2Failure to ensure that the investigation was conducted according tothe investigational plan3Failure to maintain adequate and accurate case histories that recordall observations and other data pertinent to the investigation oneach individual administered the investigational drug or employedas a control in the investigation21 CFR312.62(b)4Failure to maintain adequate records of the disposition of the drug,including the dates, quantity, and use by subject21 CFR312.62(a)5Failure to retain records required to be maintained under 21 CFRPart 312 until 2 years after the investigation was discontinued andFDA was notified21 CFR312.62(c)6Failure to ensure proper monitoring of the clinical investigations21 CFR 312.50;312.56(a)7Failure to obtain a signed investigator statement, Form FDA 1572,before permitting an investigator to participate in an investigation21 CFR312.53(c)(1)8Failure to give each participating investigator an investigatorbrochure containing the information described in 312.23(a)(5)21 CFR312.55(a)21 CFR 312.6621 CFR 312.6014
FDA Warning Letters 2010 to 20199Failure to review and evaluate the evidence relating to the safetyand effectiveness of the drug as it is obtained from the investigator21 CFR312.56(c)10Failure to submit to the FDA an annual report of the investigation21 CFR 312.3311Failure to maintain adequate records showing the receipt, shipment,or other disposition of the investigational drug21 CFR312.57(a)12Failure to maintain complete and accurate records showing anyfinancial interests of investigators subject to 21 CFR Part 5421 CFR312.57(b)13Failure to retain records and reports for two years after shipmentand delivery of the drug is discontinued and FDA has been sonotified21 CFR312.57(c)14Failure to comply with the requirements for use of aninvestigational new drug in a clinical investigation by administering21 CFR 312.40the investigational new drugs Compounds 1, 2, and 3 to subjectswithout an IND in effect15Failure to obtain prior written authorization from FDA prior tocharging for an investigational drug21 CFR312.8(a)(3)16Failure to maintain adequate and accurate case histories that recordall observations and other data pertinent to the investigation oneach individual administered the investigational drug or employedas a control in the investigation21 CFR312.62(b)17Failure to return the unused supplies of the drug to the sponsor, orotherwise provide for disposition of the unused supplies of the drugunder 21 CFR 312.5921 CFR 312.5918Repeated or deliberate submission to FDA or to the sponsor falseinformation in any required report21 CFR312.70(a)19Failure to adhere to requirements for all expanded access uses withrespect to maintaining accurate case histories and retaining recordsin a manner consistent with 21 CFR 312.6221 CFR312.305(c)(4);21 CFR312.62(b) and (c)20Failure to take adequate precautions to prevent theft or diversion ofan investigational drug that is subject to the Controlled SubstancesAct21 CFR 312.6915
FDA Warning Letters 2010 to 2019Table 7: Number of Investigator Violations During the Years 2010 to 2019.Violation 201020112012 2013201420152016201720182019Type 16511100000Type 217242111045303Type 36714412101Type 44300011101Type 51100100201Type 61011010000Type 71000000000Type 81000000000Type 91100000000Type 101000000000Type 112000000000Type 121000000000Type 131000100000Type 141000010001Type 151000000000Type 160100000000Type 170100000000Type 180010000000Type 190001000000Type 20000010000016
FDA Warning Letters 2010 to 2019DiscussionA total number of 91 Warning Letters issued by the OSI to sponsors, IRBs, andinvesti
issued to sponsors, IRBs and investigators from 2010 to 2019 and compared these findings with those of previous studies. The most critical observation made was the repetitive nature of the types of violations being cited to all three organizations, not
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