FDA WARNING_LETTER - Boehringer Ingelheim Pharma Gmbh & Co Kg - November 12, 2012

On May 6, 2013, the FDA issued a Warning Letter to Boehringer-Ingelheim Pharma GmbH & Co. KG following a November 5-12, 2012 inspection of their API and finished pharmaceutical manufacturing facility in Ingelheim am Rhein, Germany. The inspection revealed significant violations of CGMP for APIs and finished pharmaceuticals (21 CFR Parts 210 and 211), rendering their products adulterated under Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act.

Key violations included the Quality Unit's failure to thoroughly investigate critical deviations, specifically foreign particles in the (b)(4) API. The firm acknowledged potential contamination in (b)(4) API batches from 2008 and 2009, with 22 of 29 identified particle types being (b)(4), yet used these contaminated lots for (b)(4) Capsules (b)(4) µg finished product. A formal project to address this began only in July 2012.

Additionally, the firm failed to conduct thorough complaint investigations regarding foreign particles in APIs, inconsistently concluding investigations as "confirmed" or "not confirmed" for similar issues. For finished products, the firm failed to reject drug products not meeting specifications, using API batches contaminated with foreign particles for (b)(4) Capsules (b)(4) µg manufacturing,