FDA 483 - PAI Holdings, LLC. dba Pharmaceutical Associates Inc - February 22, 2019

Pharmaceutical Associates, Inc. in Greenville, SC, was inspected and received a Form 483 with four observations. The inspection revealed significant deficiencies in quality control, including inadequate investigations into discrepancies and batch failures, poor documentation practices, and incomplete batch production records. Additionally, the firm's supplier qualification program was found to be deficient, with issues in evaluating third-party auditors and timely supplier evaluations.