Amman Pharmaceutical Industries
FDA issued a warning letter to Amman Pharmaceutical Industries, a Jordanian contract manufacturer of sterile OTC and homeopathic drug products, following an August 2023 inspection that revealed serious CGMP violations including fundamental aseptic processing design flaws, inadequate environmental monitoring, pervasive data integrity breaches, and an ineffective quality control unit. The facility had shipped sterile drug products to the U.S. without completing required process simulations (media fills) or dynamic smoke studies, and laboratory records were found to be unreliable with over 50 microbial excursions contradicting the firm's claim of zero excursions over two years. FDA placed the firm on Import Alert 66-40, the firm committed to recalling all U.S.-bound drug products and suspending production, and FDA warned that failure to remediate could result in seizure, injunction, and continued refusal of admission of articles into the United States.
Flagged claims (1)
your firm stated that no such recoveries had occurred in this environment in the prior 2 years
Required actions (6)
FDA placed your firm on Import Alert 66-40 on April 28, 2023, after your response to our 704(a)(4) Request for Records sent to you on March 22, 2023, demonstrated CGMP violations related to controls for DEG/EG in high-risk components used in your drugs.
Failure to adequately address this matter may result in legal action including, without limitation, seizure, and injunction.
We acknowledge your commitment to recall all drug products and suspend production of all drugs for the U.S. market.
After you receive this letter, respond to this office in writing within 15 working days.
A commitment to have a qualified consultant conduct extensive annual audits, for at least 2 years, to assist in evaluating CAPA effectiveness after you have executed your data integrity remediation protocol.
If you plan to resume any manufacturing operations regulated under the FD&C Act, notify this office before resuming your drug manufacturing operations.
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