FDA 483 - PLD Acquisitions LLC - February 28, 2025

PLD Acquisitions LLC, an Rx and OTC drug manufacturer in Doral, FL, was cited for significant deficiencies across its quality system, laboratory controls, and complaint handling. Observations included inadequate master production records, failure to follow quality control procedures leading to inaccurate microbial data reporting, and deficient complaint and recall procedures. The findings indicate a need for comprehensive improvements in documentation, adherence to SOPs, and investigation practices to ensure product quality and safety.