Degasa S.A. De C.V. – FDA Warning Letter, Sep 8, 2017

The FDA issued a Warning Letter to Degasa S.A. De C.V. following an inspection from September 4-8, 2017, citing significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, rendering their drug products adulterated. Additionally, several products, including Dynarex Povidone Iodine Prep Solution and Dukal Povidone Iodine USP 10% Prep Solution, were deemed misbranded.

Key violations include: 1. **Inadequate Microbial Testing (21 CFR 211.165(b)):** The firm failed to implement appropriate microbial testing for antiseptic products intended for surgical preparation and infection prevention, lacking tests for objectionable microbial contamination or sterility. The FDA requires an action plan within 30 days to test retain samples of all in-market batches for microbial quality, provide test methods and specifications, and validation studies. An independent assessment of manufacturing operations for bioburden control and contamination prevention is also required. 2. **Incomplete Laboratory Records (21 CFR 211.194(a)):** The firm could not provide complete raw data for their water system qualification, with half a year's data reportedly lost. Other missing data included sample weights, test methods, calculation records, and water monitoring data. The water system was deemed unsuitable for its intended use. The FDA demands a comprehensive independent evaluation of the water system design, a CAPA plan for installation