Warning Letter: FDA criticizes Supplier Qualification

Recommendation

5/6 October 2023
Heidelberg, Germany

Quality Culture
People Empowerment in GMP

Supplier Qualification and the respective contracts in outsourcing activities are always hot topics in inspections. The U.S. Food and Drug Administration (FDA) recently posted a Warning Letter sent to a South Korean pharmaceutical company criticizing their quality and supplier oversight.

For example, the company "lacked a QU with appropriate oversight over the drug manufacturing and testing operations" which were conducted by their contracted facilities. The company wasn't able to assure manufacturing records and test results were adequately reviewed and approved, and it seems that drug products batches were released without a complete "satisfactory product quality testing" by the contractor. Even worse, the contract manufacturer used was listed on FDA's Import Alert 66-40 (Detention Without Physical Examination of Drugs From Firms Which Have Not Met Drug GMPs). The company wasn't aware of this and had to be informed during the inspection.

In the Warning Letter, FDA pointed out that "FDA regards contractors as extensions of the manufacturer" and recommends that the company will "properly evaluate and qualify" all their suppliers and change the source of supply, where appropriate.

The inspected company has now also been placed on Import Alert 66-40. Until all violations are corrected completely, FDA may withhold approval of any new applications or supplements listing the company as a drug manufacturer.