26/27 January 2021
On behalf of the European Compliance Academy, the team of Concept Heidelberg regularly analyses the inspectional reports from Warning Letters issued by the FDA. They concern both medicinal products and medical devices. We reported about the Top 5 hit list of the Warning Letter statistics with regard to medical devices for fiscal year 2013 (from 1st October 2012 to 30 September 2013) in our GMP News dated 12 November 2013.
An overview of the inspectional reports issued at medical devices manufacturers directly after the FDA inspection (Form 483) has been recently published by the FDA for fiscal year 2014 (1st October 2013 - 30 September 2014). Unlike the number of Warning Letters 2013, the total number of 483 documents decreased - for the first time since 2008. One year ago, 1,099 "483" forms were issued, whereas in fiscal year 2014 it was "only" 972. This is roughly comparable with the figures of 2010 (976).
The FDA lists in detail all the "Findings" in a table form and ranks them according to their frequency. The ranking of 483 Forms largely corresponds to the Warning Letter statistics from 2013: in 2014, place 1 and 2 went to CAPA deficiencies (21 CFR 820.100 (a)) and to Complaints (21 CFR 820.198 (a)). Deviations in "Purchasing Controls" (21 CFR 820.50) got place 3 of the 483 ranking, whereas they got place 5 in the Warning Letters statistics from 2013. The statistics of 483 Forms ranks deficiencies with regard to the topic process validation (21 CFR 820.75 (a)) on place 4. Process validation got place 6 in the Warning Letter statistics from 2013. Place 5 of the 483 deficiencies goes to "Medical Device Reporting" (21 CFR 803.17) - a section which isn't assessed for the Warning Letter statistics as it isn't included in the Quality System Regulations (21 CFR 820, medical devices GMP).
Conclusion: The statistics of the 483 documents for fiscal year 2014 is largely consistent with the Warning Letter statistics of fiscal year 2013.
For more details please see the 483 ranking for fiscal year 2014 - "FY 2014 Inspectional Observation Summaries".