FDA Posts 483 of PQ Drug Outsourcing Facility

A 10/2022 FDA inspection of drug outsourcing facility PQ Pharmacy of Brooksville, FL resulted in a just-posted seven-item Form FDA-483. During the inspection, agency investigators cited the firm’s quality control unit because it lacked the authority to review production records to assure that no errors had occurred. The 483 also says that the quality unit did not fully investigate laboratory test results before releasing finished drug products. Specifically, the 483 says PQ did not have a validated test method for assay testing of certain ophthalmic solutions before their release and distribution.

Additionally, FDA says that an inadequate number of batches of each drug product were tested to determine an appropriate expiration date and the company failed to maintain records of such data. It also says the written stability program for drug products did not include reliable test methods.