New Jersey-based AACE Pharmaceuticals has been slammed in an FDA warning letter citing significant violations by its contract manufacturer Brassica Pharma, including substandard sanitary conditions and fabricated lab records.
The warning letter, which was issued May 13 and posted on the regulatory agency’s website this week, comes in the wake of a January 2024 inspection of Brassica’s foreign facility used to produce ophthalmic drugs for AACE.
That facility, located in Maharashtra, India, was inspected from Jan. 15-19, 2024, and was initially issued a Form 483 for infractions that ranged from widespread and routine data falsification to substandard environmental monitoring meant to ensure the sterility of drugs.
The FDA then issued a warning letter to Brassica in July.
In its warning letter to AACE, the agency slammed the company for importing shipments of eye ointments and distributing them to customers despite Brassica being put on an import alert in January 2024. The FDA visited AACE's New Jersey facility in November, according to the warning letter.
“Your firm’s quality unit released Lubricant PM Ointment for distribution without adequate procedures to ensure that the ophthalmic drug products produced for your firm met appropriate quality attributes,” the agency said in the letter.
After Brassica's manufacturing issues came to light, eye ointments from AACE and other firms were at the center of a nationwide recall last year.
In the recent warning letter, the FDA said AACE itself had uncovered several manufacturing problems at Brassica in September 2020 but still qualified the firm as an approved CMO. AACE requalified Brassica in 2023, without evaluating whether it had taken corrective action to address its problems, according to the letter.
The FDA found AACE’s response to earlier concerns inadequate and told the company it was responsible for “ensuring that the drugs you distribute are not adulterated and are manufactured in accordance with CGMP requirements.”
If AACE doesn’t follow the agency’s corrective actions, the company could lose its import license and face legal action, according to the letter.