ASP Cares – FDA 483, Jul 23, 2015

This FDA Form 483 document outlines several deficiencies observed during an inspection of a drug manufacturing facility. The observations primarily concern the production and control of sterile drug products.

Key violations include: * **Personnel Clothing:** Clothing worn by personnel in manufacturing and processing areas was deemed inappropriate for their duties. * **Environmental Monitoring:** The system for monitoring environmental conditions in aseptic processing areas was found deficient. * **Sterilization Validation:** Procedures to prevent microbiological contamination lacked validation of the sterilization process. * **Cleaning and Disinfection:** The system for cleaning and disinfecting rooms and equipment in aseptic processing areas was deficient. * **Equipment Maintenance:** Systems for maintaining equipment used to control aseptic conditions were inadequate. * **Sterility Testing:** Each batch of sterile drug product was not laboratory tested for conformance to sterility requirements. * **Stability Testing:** A written program to assess drug product stability characteristics was absent. * **Product Rejection:** Drug products failing to meet established specifications were not rejected. * **Batch Records:** Batch production and control records lacked complete information for each batch.

These findings indicate significant issues with the facility's quality system, particularly concerning aseptic processing, environmental controls, product testing, and record-keeping, which are critical for ensuring the safety and efficacy of sterile drug products.