Quality Trend Analysis In Warning Letters Nikunj Vasoya


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This research work intended to give readers a sense of FDA (Food and Drug Administration) activity and oversight of quality system regulation in terms of warning letter issued to medical device companies. The study analyzes the quality issues and trend contained in warning letters issued to medical device manufacturers by the FDA. FDA’s online Warning Letter Index was reviewed for warning letters issued specific to Medical Device Manufacturers from different countries under the violation subject “cGMP/QSR/Medical Device/Adulterated, Medical device reporting regulation/Misbranded, cGMP/QSR/Manufacture/Packing/Storage Installation/Adulterated” for the period January 2008 through December 2009. The resultant 137 warning letters were reviewed and number of citations of the individual paragraphs of 21 CFR (Code of Federal Regulation) Part 820 Quality System Regulations was calculated. This study identified ten different FDA regulated areas in which most medical device companies commonly received enforcement letter. Quality control tool such as Pareto chart analysis was used to find the highest cited FDA regulated area. Among which CAPA identified as the 1st deficiency, especially Part 802.100 (a) (3), “Identifying the action(s) needed to correct and prevent recurrence of nonconforming product and other quality problems” was exceedingly cited by FDA. This was followed by deficiencies in Part 820.198 (a), lack of established procedures for evaluating complaints received to determine whether or not the complaint should be filed as a Medical Device Report. Deviations regarding Design validation are at 3rd position. FDA cited medical device companies that did not have a procedure for validating the device design as well as failure to perform risk analysis study while performing validation study. Warning Letters are very informative tool with regards to the evaluation of focal points in FDA’s inspection. These letters are important as they show what specific things FDA looks at while inspecting the facilities.

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  • Letter issued by the FDA, citing violations identified during its routine or for-cause audit of investigators/study sites. It usually requires immediate response that includes corrective actions from the investigator.
  • 87 WLs – (86%) WLs were associated with Quality system regulation (QSR) Remaining 14 (14%) WLs referred to deficiencies in medical device reporting, lacking premarket approval, deviations in investigational device exemptions
  • From the Pareto analysis, it becomes clear that deviations/deficiencies in first 10 FDA regulated areas are responsible for 80% of the enforcement letter from FDA. Deviations in remaining 5 regulations are liable for 20% of WLs.
  • Results of Pareto analysis for Year-2009 much identical to those produced in Year-2008. Top ten list of FDA regulation cited extensively in the Year of 2009 were similar to that cited in Year 2008 and also 80% of these were responsible for the FDA enforcement letter.
  • Deficiencies in “Corrective and Preventive Action” i.e. Part 820.100 were again at the 1 st rank, closely followed by Part 820.198, “Complaint Files” which was at the 2 nd position. FDA found that most medical device companies fail to determine whether the complaint represents an event which must be reported to FDA. FDA’s district offices in Cincinnati and Dallas were more concerned about the 21 CFR Part 820.30 which is “Design Control”. FDA’s common citations within Part 820.30 were, 1) Firm fails to establish and maintain procedures; 2) Firms fails to perform risk analysis to ensure that device is safe and effective for its intended use; 3) design validation fails to ensure that device conform to defined use needs and intended use; 4) firm fails to validated device software; and 5) Validation activities were poorly or not documented. The number of citation concerning “Process validation, purchasing control, quality audits, inadequate training decline significantly; however even if less frequently cited, these topics were still at to be found in top ten list.
  • Quality Trend Analysis In Warning Letters Nikunj Vasoya

    1. 1. Quality Trend Analysis in FDA’s Warning Letter Prepared by: Nikunj Vasoya Prepared by Nikunj Vasoya
    2. 2. Overview <ul><li>Medical Device </li></ul><ul><li>Warning Letter </li></ul><ul><li>Part 820 Quality System Regulations </li></ul>Prepared by Nikunj Vasoya
    3. 3. Quality Trend Analysis <ul><li>Year -2008 </li></ul><ul><ul><li>Total 435 WLs </li></ul></ul><ul><ul><li>101 WLs </li></ul></ul><ul><li>Year-2009 </li></ul><ul><ul><ul><li>Total 464 WLs </li></ul></ul></ul><ul><ul><ul><li>72 WLs </li></ul></ul></ul>Prepared by Nikunj Vasoya
    4. 4. Warning Letter Categories Prepared by Nikunj Vasoya
    5. 5. Pareto Chart Analysis Prepared by Nikunj Vasoya
    6. 6. Pareto Chart Analysis Prepared by Nikunj Vasoya
    7. 7. Top 5 citations by FDA <ul><li>21 CFR Part 820.100 – Corrective and Preventive Action </li></ul><ul><li>21 CFR Part 820.198 – Complaint Files </li></ul><ul><li>21 CFR Part 820.30 – Design Controls </li></ul><ul><li>21 CFR Part 820.20 – Management Responsibilities </li></ul><ul><li>21 CFR Part 820.80 – Receiving, in-process, and finished device acceptance </li></ul>Prepared by Nikunj Vasoya
    8. 8. Quality Trend by FDA’s Offices Prepared by Nikunj Vasoya 1 st 2 nd 3 rd Center for Devices And Radiological Health 820.100(a) 820.198(a) 820.30 New Orleans District Office 820.100(a) 820.198(a) 820.20 New England District Office 820.100(a) 820.198(a) 820.20; 820.75 Los Angeles District Office 820.100(a) 820.75(a) 820.20; 820.80(d) Cincinnati District Office 820.100(a) 820.30(a)-(j) 820.198 Dallas District Office 820.30 820.198 820.50 Florida District Office 820.100(a) 820.22 820.198 Chicago District Office 820.100(a) 820.50(a); 820.80 820.198(e)
    9. 9. How to Avoid Warning Letters? <ul><li>Effective CAPA Investigation program </li></ul><ul><li>Complaint files system </li></ul><ul><li>Quality management system </li></ul><ul><li>Design validation of device </li></ul><ul><li>Internal quality audit system </li></ul><ul><li>Effective audit system for suppliers and vendors </li></ul>Prepared by Nikunj Vasoya
    10. 10. References <ul><li>http://www.fda.gov/MedicalDevices/default.htm </li></ul><ul><li>http://en.wikipedia.org/wiki/Medical_device </li></ul><ul><li>http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820 </li></ul><ul><li>http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2009/default.htm </li></ul><ul><li>http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2008/default.htm </li></ul><ul><li>http://www.gmp-compliance.org/eca_news_1740_rss.html </li></ul>Prepared by Nikunj Vasoya
    11. 11. <ul><li>Q & A </li></ul><ul><li>Thank you all!!! </li></ul>Prepared by Nikunj Vasoya