API from Unregistered Companies Entered US, According to FDA

FDA sent a warning letter, dated April 20, 2017, to Sal Pharma after an inspection of the company’s facility at 1-7-171/2 Bakaram, Hyderabad, Andhra Pradesh found that the company had failed to provide all quality and regulatory information about its API manufacturer to its customers. It was determined that two of the company’s API suppliers were not registered with FDA as drug manufacturers at the time of the inspection. The FDA inspection was conducted from June 27 to July 1, 2016.

The warning letter states that inspectors found that the company had omitted names and addresses of the original manufacturer of the company’s API on certificates of analysis (COA) sent to customers. According to FDA, the company created its COA by replacing the original manufacturers’ information with Sal Pharma’s letterhead. The company also shipped API to the United States under import declaration that Sal Pharma was the manufacturer, when it fact API was manufactured by two companies not registered with FDA as drug manufacturers. “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,” FDA stated in the letter.

FDA also cited the company for failure to relabel and hold API under current good manufacturing practice control. According to the warning letter, the company would pick up API from various suppliers and relabel the API in their vehicle and then transfer the relabeled product to its clearing agent. Sal Pharma was unable to confirm if the clearing agent properly stores the 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,” the agency stated.

The agency asked that the company provide FDA with written procedures for the transfer of information to customers, a plan to establish and implement CGMP procedures, and corrective actions for maintaining storage conditions. FDA also recommended the company acquire a CGMP consultant.

Source: FDA