FDA 483 - PLD Acquisitions LLC - September 21, 2021

PLD Acquisitions LLC D/B/A Avema Pharma Solutions, a prescription and OTC drug manufacturer in Doral, FL, was cited for multiple significant deficiencies during an FDA inspection. Key issues include inadequate water system controls, widespread data integrity problems in laboratory records, failure to follow established test procedures, and insufficient equipment cleaning and process control documentation. Several observations, including equipment cleaning and investigation failures, were repeat findings from a previous inspection.