FDA Warns AACE Pharmaceuticals Over Lax CMO Oversight

The FDA has issued a Warning Letter to AACE Pharmaceuticals for inadequate qualification and oversight of its contract manufacturer (CMO), which produced ophthalmic drugs later subject to recalls and an Import Alert. Despite identifying CGMP violations at the CMO, AACE approved and re-qualified the facility without confirming that corrective actions were effective.

FDA criticized AACE for releasing products without proper assurance of quality and for relying solely on certificates of analysis (COA), instead of robust qualification procedures. The agency emphasized that COA checks do not replace the need for thorough CMO evaluation, audits, and ongoing monitoring.

AACE has since updated its procedures, but the FDA demands more—specifically, detailed plans on assessing GMP deviations, disqualifying CMOs, and managing overall supplier qualification. The case underscores the critical role of quality risk management in outsourcing pharmaceutical production.

23-06-2025