FDA WARNING_LETTER - MEDGEL PRIVATE LIMITED - January 27, 2023

The FDA issued a Warning Letter to Medgel Private Limited following a January 23-27, 2023, inspection of their Pithampur, India drug manufacturing facility, identifying significant CGMP violations. The facility's drug products are deemed adulterated.

Key violations include: 1. **Inadequate Investigations (21 CFR 211.192):** The firm failed to thoroughly investigate out-of-specification (OOS) assay results for bulk drug products, lacking scientific justification for invalidating OOS results and attributing root causes to sample preparation errors without effective CAPAs. Humidity excursions during production and in stability chambers were also inadequately investigated, with raw data deleted monthly. 2. **Quality Control Unit Failures (21 CFR 211.22):** The Quality Unit failed to ensure CGMP compliance and product specifications, demonstrating inadequate oversight. This included non-contemporaneous documentation, a repeat observation from a 2019 inspection, with CAPAs deemed insufficient and lacking comprehensive scope. Data integrity systems were also inadequate. 3. **Component Testing Deficiencies (21 CFR 211.84(d)(1) and 211.84(d)(2)):** The firm failed to adequately test incoming components for identity and conformity, specifically lacking diethylene glycol (DEG) and ethylene glycol (EG) limit testing for high-risk ingredients like glycerin