FDA hits Colombian manufacturer, already on import alert, with warning letter

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The FDA has cited a manufacturing plant in Cali, Colombia, for failing to address several quality control issues in production of materials bound for the United States. (FierceHealthcare)

The inability of a chemical manufacturing plant in Colombia to validate quality control procedures for the production of active pharmaceutical ingredients bound for the United States has resulted in a warning letter from the FDA.

Proquimes S.A., a 44-year-old manufacturing facility in Cali, Colombia, failed to provide evidence of quality control procedures in response to an itemized FDA request a year ago. On December 3, 2020, the FDA placed all products manufactured by Proquimes on import alert. 

In response to an FDA request to detail its procedures for all U.S.-marketed APIs, the company indicated that it did not perform process validation and therefore could not provide documentation. The agency's second request for the same information two months later was met with the same response.

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Proquimes was similarly cited for failing to conduct qualification checks of manufacturing equipment and to validate procedures for cleaning and maintaining its equipment. The manufacturer further failed to test the identity of each batch of incoming production materials, the FDA said.

Now, the agency has asked Proquimes to provide a remediation plan that ensures management oversight throughout the manufacturing process. The FDA is requesting Proquimes to provide written procedures to ensure the qualification of equipment and facilities and for validating the identity and quality of raw materials as they arrive at the plant and throughout the manufacturing process.

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To meet these requirements, the FDA has recommended that the company secure a qualified consultant to perform a comprehensive audit to ensure current good manufacturing practice (cGMP) compliance.

The FDA has given Proquimes 15 days to respond with a plan to meet its compliance requirements.