FDA WARNING_LETTER - Meridian Medical Technologies, LLC a Subsidiary of Kindeva Drug Delivery, L.P. - March 24, 2017

The FDA issued a Warning Letter to Meridian Medical Technologies, Inc. (MMT), a Pfizer Company, following an inspection of their Brentwood, Missouri facility from February 20 to March 24, 2017. The facility manufactures combination products, specifically EpiPen and EpiPen Jr. auto-injectors, which are deemed adulterated due to significant violations of current good manufacturing practice (CGMP) requirements for both drug (21 CFR parts 210 and 211) and device (21 CFR part 820) constituent parts. Key violations include MMT's failure to thoroughly investigate unexplained discrepancies or failures of batches and components, particularly concerning EpiPen products, which led to patient deaths and severe illness (21 CFR 211.192). The firm also failed to establish and follow adequate written procedures for handling complaints, with an inadequate classification scheme and lack of scientific basis for trend analysis (21 CFR 211.198(a)). Furthermore, MMT did not adequately analyze quality data to identify causes of nonconforming products (21 CFR 820.100(a)(1)), nor did it establish and maintain adequate procedures for verifying (21 CFR 820.30(f)) and validating (21 CFR 820.30(g)) device designs. The letter notes these are repeat violations from a 2014 inspection, indicating inadequate oversight. MMT's responses were deemed insufficient. The FDA requires prompt corrective actions, including comprehensive reviews, revised procedures, and statistical analysis, within 15 working days to prevent legal action, including seizure and injunction, and potential impact on federal contracts and application approvals. The firm was also advised to contact the Drug Shortages Staff if supply disruption is anticipated.