AACE Pharmaceuticals, Inc. – FDA Warning Letter, Nov 22, 2024

The FDA issued a Warning Letter to AACE Pharmaceuticals, Inc. on May 13, 2025, following an inspection from November 12-22, 2024. The inspection was prompted by violative conditions found at Brassica Pharma Private Limited, a contract manufacturing organization (CMO) used by AACE Pharmaceuticals for ophthalmic drugs.

The FDA inspection of Brassica (January 15-19, 2024) revealed significant CGMP violations, including poor aseptic practices, fabricated microbiology records, microbial recoveries, inadequate media fill programs, and use of dirty gowning. These issues rendered Brassica's products adulterated under 21 U.S.C. 351(a)(2)(B). Brassica was placed on Import Alert 66-40 (January 30, 2024), recalled all in-expiry drug products (February 22, 2024), and received a Warning Letter (July 11, 2024).

AACE Pharmaceuticals, as a distributor, received and introduced adulterated drugs (Lubricant PM Ointment) into interstate commerce, violating 21 U.S.C. 331(c) and 331(a). The FDA found AACE's quality control unit failed to establish adequate supplier qualification procedures (21 CFR 211.