Tampa Firm Warned for Investigational, Procedural Issues

The FDA warned Clover Custom Blending after an investigation of its Tampa, Florida-based manufacturing plant revealed uninvestigated out-of-specification results, missing written procedures and other deficiencies.

The agency’s May inspection found that the firm released sunscreen lotion product that failed to meet established potency specifications for the product’s three active ingredients. The ingredients were found to be either super-potent or sub-potent. The firm believed the OOS results were due to a contract laboratory error, but did not initiate an investigation before it released the batch.

Clover responded to the agency’s inspection observations, saying it would draft a standard operating procedure for handling future OOS results, but the agency found the response inadequate, as the firm did not provide a copy of the SOP or demonstrate it investigated OOS results.