FDA WARNING_LETTER - Gilead Sciences Inc - February 12, 2010

The FDA issued a Warning Letter to Gilead Sciences, Inc. following a January 25 to February 12, 2010 inspection of their San Dimas, CA pharmaceutical manufacturing facility. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations for Finished Pharmaceuticals (21 CFR Parts 210 and 211), rendering their drug products adulterated under section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act. The firm's March 2, 2010 response was deemed inadequate.

Key violations included failure to maintain adequate separate areas for aseptic processing to prevent contamination (21 CFR 211.42(c)(10)), such as an inadequately constructed aseptic processing room and an insufficient environmental monitoring program. The firm also failed to follow appropriate written procedures to prevent microbiological contamination of sterile drug products (21 CFR 211.113(b)), with personnel observed making excessive movements and not using proper sterile equipment containers. Additionally, Gilead lacked adequate written procedures for production and process controls (21 CFR 211.100(a)), leading to an unvalidated process re-validation. Investigations into batch failures to meet specifications were inadequate (21 CFR 211.192), with defective tablets being culled instead of thoroughly investigated. Finally, equipment was not cleaned and maintained at appropriate intervals (21 CFR 211.67(a)), lacking rationale for cleaning frequencies.

The FDA noted concerns about the Quality Unit's inadequate responsibilities and authority, citing reliance on sorting defective tablets. Gilead must promptly correct these violations, provide a written response within fifteen working days detailing corrective actions, recurrence prevention, and supporting documentation. Failure to comply may result in legal action, impact federal contracts, and hinder drug application approvals.