Drugs

‘Significant’ CGMP Violations at Amman Pharmaceutical

An 8/7-8/15/2023 FDA inspection at the Amman Pharmaceutical Industries drug manufacturing facility in Amman, Jordan, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 2/14 Warning Letter says specific violations were:

failing to perform operations within specifically defined areas of adequate size and to have separate or defined areas or such other control systems necessary to prevent contamination or mix-ups in aseptic processing areas;
failing to establish and follow appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile, including validation of all aseptic and sterilization processes;
failing to ensure that laboratory records included complete data from all tests necessary to ensure compliance with established specifications and standards; and
failing 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.

The letter says the firm’s quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs it manufactures. It reminds Amman that it is responsible for the quality of the drugs it produces as a contractor, regardless of agreements in place with product owners.

The agency acknowledges Amman’s commitment to recall all drug products and suspend production of all drugs for the U.S. market. It recommends the firm engage a qualified consultant to evaluate its operations and assist it in meeting CGMP requirements if the company intends to resume manufacturing drugs for the U.S. market.

FDA placed Amman Pharmaceutical on a 4/28/2023 Import Alert. The company was told to correct any violations promptly and to respond with a list of specific steps it has taken to address the violations and prevent their recurrence, with a schedule for completing the corrections.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome