FDA 483 - Central Admixture Pharmacy Services, Inc. - December 04, 2015

On December 4, 2015, the FDA issued a Form 483 to Central Admixture Pharmacy Services, Inc., a producer of sterile drugs located at 37497 Schoolcraft Rd, Livonia, MI. The inspection, conducted from November 16 to December 4, 2015, identified five observations related to the facility's sterile drug production.

**Key Observations:**

1. **Inadequate Procedures to Prevent Microbiological Contamination:** * Non-sterile items were not fully decontaminated (e.g., a large glass drug component bottle was not sanitized on the back and underside). * Operators exhibited quick, rather than slow and deliberate, movements during critical aseptic operations. * Exposure to first air from HEPA filters was not always maintained for critical surfaces (e.g., gloved hands directly above a sanitized septum). * Raw material bottles were placed underneath equipment in the ISO 5 area immediately prior to filling. * Insufficient contact time for sterile spray on raw material bottle septums.

2. **Inappropriate Personnel Clothing:** * Gowning in ISO 5 areas was inadequate, leaving facial skin exposed around the eyes and forehead. * Sterile gowns were stored in the ISO 8 room after use, compromising their sterility.

3. **Deficient Cleaning and Disinfecting of Ase