ImprimisRx NJ – FDA Warning Letter, Aug 5, 2022
On May 26, 2023, the FDA issued Warning Letter WL # 657453 to ImprimisRx NJ, LLC, following an inspection from July 11 to August 5, 2022, at their Ledgewood, NJ facility. The inspection revealed serious deficiencies in the production of sterile drug products, posing patient risks.
The FDA cited several violations under the Federal Food, Drug, and Cosmetic Act (FDCA). Drug products intended to be sterile were found to be adulterated under section 501(a)(2)(A) due to insanitary conditions. Specific observations included stained HEPA filters in an ISO 5 area, facility design permitting influx of lesser quality air, fiber-like particles and peeling caulk in the cleanroom, inadequate dynamic smoke studies, improper operator aseptic technique (re-entry into ISO 5 without sanitization), and failure to disinfect materials during transfer from ISO 7 to ISO 5.
Additionally, the firm released and distributed subpotent Timolol-Latanoprost PF (0.5/0.005%) Ophthalmic Solution, causing it to be adulterated under section 501(c) and misbranded under section 502(a) because its strength differed from the label claim. This subpotency issue for Timolol-Latanoprost was a recurring problem, noted in both 2019 and
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