CGMP Deviations
1. Failure to transfer all quality or regulatory information received from the API manufacturer to your customers.
You omitted the names and addresses of the original manufacturers of your API on certificates of analysis (COA) you issued to your customers. You generated your COA by replacing the original manufacturers’ information with your letterhead.
During our inspection, we found that two of your suppliers were not registered with the FDA as drug manufacturers at the time of inspection. However, you shipped API from these firms to the United States, and declared on importation documents and the COA that you provided to your customers that you were the manufacturer. Your failure to declare the original manufacturers on your importation documents and COA provided to your customers enabled the entry of unregistered firms’ products into the United States.
Customers and regulators rely on COA for information about the quality and source of drugs and their components. Omitting information from COA compromises supply-chain accountability and traceability, and may put consumers at risk.
2. Failure to relabel and hold API under appropriate CGMP controls.
During the inspection, you stated that you (b)(4) drive your car and pick up API from various suppliers, relabel API (b)(4) with Sal Pharma’s information, and then transport API to your clearing agent. You stated that you cannot confirm whether or not your clearing agent securely stores API in a temperature-controlled environment.
Repackaging, relabeling, and holding of API must be performed under appropriate CGMP controls to avoid loss of API identity or purity.
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