FDA 483 - hiers enterprises, llc - November 14, 2018

This FDA Form 483 documents observations from an inspection, indicating significant deficiencies in the facility's manufacturing and quality control processes for drug products, particularly those purporting to be sterile.

Key violations include the absence of established, written, and followed procedures to prevent microbiological contamination of sterile drug products. Personnel clothing was deemed inappropriate for their duties. Aseptic processing areas exhibited multiple deficiencies: inadequate environmental monitoring systems, insufficient cleaning and disinfection procedures for rooms and equipment, and a deficient air supply system lacking high-efficiency particulate air filters under positive pressure.

Furthermore, the facility lacked a written testing program to assess drug product stability. Batches of sterile and pyrogen-free drug products were not laboratory tested for conformance. Drug products required to be free of objectionable microorganisms were not subjected to appropriate laboratory testing. Final product release procedures were deficient, as they did not include appropriate laboratory determination of conformance to final specifications, identity, and strength of active ingredients. Lastly, components liable to objectionable microbiological contamination were not microbiologically tested before use. These observations highlight critical deficiencies across quality systems, manufacturing controls, and laboratory testing, impacting product sterility, quality, and safety.