FDA criticises Supplier Qualification in Warning Letter

Although the US Food and Drug Administration FDA currently carries out almost no on-site inspections (we reported), Warning Letters continue to be issued; in January, for example, to a pharmaceutical manufacturer in Florida.

The inspection took place in May 2020 and besides the usual observations on process validation and the handling of OOS results, this time it was also about supplier qualification.

According to the FDA, the Quality Unit (QU) "failed to adequately oversee the quality of components received". For example, tests on an active pharmaceutical ingredient (API) yielded different results than those indicated on the supplier's certificate of analysis; in some cases there were deviations of 7.8%. Nevertheless, the API was used to formulate the final product. In addition, the FDA took a sample of a batch and its sample results did not correspond to the USP specification for the corresponding API.

According to the existing quality agreement, the inspected company is responsible for qualifying the approved manufacturers. However, at the time of the inspection, a new API supplier was not qualified as required.

The response to the inspection report recognised the need to intensify the cooperation with the API manufacturer. The company had committed to report test results deviating by more than 3% to the API manufacturer. In addition, the company wanted to contact the manufacturer of the HPLC systems to "purchase and validate the necessary equipment".

This was not sufficient for the FDA. What was missing was a description of when and how the API supplier should be qualified and a justification for how it was determined "when differences in API assay need to be investigated". Furthermore, a retrospective review of the test results for the previous API supplier was missing. As a result, the next step was now the Warning Letter to Allay Pharmaceuticals.