AACE Pharmaceuticals, Inc.

Warning LetterOpen

Mr. Atul B. Mehta President, Co-Chairman, and Co-Founder AACE Pharmaceuticals, Inc. 15 Gardner Road Fairfield , NJ 07004 United StatesFEI 3013433273Issued May 13, 2025Center for Drug Evaluation and Research (CDER)

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3013433273.

Violations2

Issue DateMay 13, 2025

Product TypeDrugs

StatusOpen

Letter Details

Firm: AACE Pharmaceuticals, Inc.
Location: Mr. Atul B. Mehta President, Co-Chairman, and Co-Founder AACE Pharmaceuticals, Inc. 15 Gardner Road Fairfield , NJ 07004 United States
FEI Number: 3013433273
Country: United States
Issue Date: May 13, 2025
Issuing Office: Center for Drug Evaluation and Research (CDER)
Product Type: Drugs
Status: Open

Summary

AACE Pharmaceuticals received a warning letter for distributing adulterated ophthalmic drugs, including Lubricant PM Ointment, manufactured by their contract manufacturer Brassica Pharma Private Limited in violation of Current Good Manufacturing Practice (CGMP) regulations. FDA inspections of Brassica revealed critical manufacturing defects including poor aseptic practices for sterile drug production, fabricated microbiology records, microbial contamination in ISO 5 manufacturing areas, inadequate media fill and airflow studies, and use of ripped and visibly dirty gowning in aseptic processing areas. AACE's receipt and introduction of these adulterated products into interstate commerce violated the Federal Food, Drug, and Cosmetic Act, making the company responsible for distributing drugs manufactured under substandard conditions.

AACE Pharmaceuticals, Inc. FDA Warning Letter, May 13, 2025