As per the Warning Letter, FDA criticizes Supplier Qualification

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

For instance, the company majorly lacked in a QU with appropriate oversight over the drug manufacturing and testing operations which were performed by their contracted facilities. The company wasn't able to ensure manufacturing records and test results were precisely reviewed and approved, and it seems that drug products batches were released without a complete satisfactory testing of product quality by the contractor. Even worse, the contract manufacturer utilized 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 was not known of this and had to be informed during the inspection.

In the Warning Letter, FDA highlighted that FDA regards contractors as extensions of the manufacturer and suggests that the company will properly examine and qualify all their suppliers and change the source of supply, where necessary.

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