FDA 483 - Essential Pharmacy Compounding - May 22, 2015

This FDA Form 483 document outlines multiple deficiencies observed during an inspection, indicating significant issues with the facility's quality system and manufacturing practices, particularly concerning sterile drug product production.

Key violations include: * **Sterilization Process Validation:** Procedures for preventing microbiological contamination of sterile drug products lack adequate validation of the sterilization process. * **Personnel Gowning:** Clothing worn by personnel in drug product processing areas is inappropriate for their duties. * **Environmental Monitoring:** Aseptic processing areas have deficient systems for monitoring environmental conditions. * **Discrepancy Investigations:** There is a failure to thoroughly review unexplained discrepancies, regardless of batch distribution status. * **Facility Sanitation:** Buildings used for manufacturing, processing, packing, or holding drug products are not maintained in a clean and sanitary condition. * **Component Testing:** Components are not tested for conformity with all appropriate written specifications for purity, strength, and quality. * **Equipment Cleaning Procedures:** Written procedures for the cleaning and maintenance of equipment and utensils are not established. * **Material Handling Procedures:** Written procedures for the receipt, identification, storage, handling, sampling, testing, approval, and rejection of components, drug product containers, and closures are not followed. * **Stability Testing:** No written testing program is designed to assess the stability characteristics of drug products. * **Laboratory Controls:** Laboratory controls do not include determining conformance to appropriate specifications for drug products.