Lupin Limited – FDA Warning Letter, Dec 4, 2018

On September 10, 2019, the FDA issued a Warning Letter to Lupin Limited Unit 1 (FEI 3002807511) in Mandideep, Madhya Pradesh, India, following an inspection from November 26 to December 4, 2018. The letter cited significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals (21 CFR parts 210 and 211) and active pharmaceutical ingredients (API), rendering their drugs adulterated under section 501(a)(2)(B) of the FD&C Act.

Key violations included: 1. **Inadequate Investigations (21 CFR 211.192):** The firm failed to thoroughly investigate out-of-specification (OOS) assay results for multiple drug products since 2016, often closing investigations without an assignable root cause and releasing batches based on retest results. Corrective and preventive actions (CAPA) were insufficient. 2. **Insufficient Production and Process Control Procedures (21 CFR 211.100(a)):** The process validation for a specific drug product was inadequate, lacking identification of variation sources and demonstration of ongoing control, especially concerning non-uniformity after maximum hold times and during the product lifecycle. 3. **Inadequate Equipment Cleaning and Maintenance (21 CFR 2