> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Inspection Issue at AACE Pharmaceuticals
- URL: https://www.fdaweb.com/inspection-issue-at-aace-pharmaceuticals/
- Published: 2025-05-27T12:00:00.000Z
- Updated: 2026-09-14T15:12:46.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159244

An 11/12-11/22/2024 FDA inspection at the AACE Pharmaceuticals drug manufacturing facility in Fairfield, NJ, was conducted after a 1/15-1/19/2024 agency inspection found violative conditions at Brassica Pharma Private Limited, a Mumbai, India, contract manufacturer used by AACE to produce ophthalmic drugs. A 5/13 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/aace-pharmaceuticals-inc-701310-05132025?ref=fdaweb.com) says the Brassica inspection [found](https://www.fdaweb.com/brassica-pharma-hit-with-10-item-fda-483/) significant current good manufacturing practice (CGMP) violations for finished drugs.

The letter says the AACE inspection found the company failed to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products. It also lacked the authority to review production records to assure that no errors occurred or, if errors occurred, that they were fully investigated.

FDA acknowledges the company’s commitment to discontinue distributing AACE Pharmaceuticals Lubricant PM Ointment manufactured by Brassica. It asks AACE to clarify whether it intends to distribute ophthalmic or sterile drugs in the U.S. It reminds AACE that it is responsible for the quality of drugs produced by a contract manufacturer and recommends that AACE engage a qualified consultant to assist it in meeting CGMP requirements.

AACE was told to correct the violations promptly and to respond with a list of specific actions it has taken to address the violations and prevent their recurrence, with a schedule for completing the corrections.