FDA 483 - College Pharmacy, Inc. - January 17, 2018

This FDA Form 483 document outlines several observations made during an inspection of a facility involved in aseptic processing and the production of highly potent and hazardous drugs.

**Key Observations:**

* **Inadequate Product Evaluation and Remedial Action:** The facility failed to adequately evaluate products and take remedial action when actionable microbial contamination was found in the ISO 5 classified aseptic processing area during production. * **Cross-Contamination Risk (Highly Potent Drugs):** Insufficient cleaning of work surfaces and utensils was observed during the production of highly potent drugs, posing a risk of cross-contamination. * **Improper Gowning Procedures:** Personnel were observed donning gowning apparel improperly, which may have led to contamination of the apparel. * **Non-Sterile Disinfectants/Wipes:** Disinfecting agents and cleaning wipes used in the ISO 5 classified aseptic processing areas were not sterile. * **Facility Design Issues (ISO 5 Area):** The ISO 5 classified aseptic processing areas contained equipment or surfaces that were difficult to clean and generated particles. * **Cross-Contamination Risk (Hazardous Drugs):** Inadequate cleaning of utensils was noted during the production of hazardous drugs, creating a potential for cross-contamination.

These observations indicate deficiencies in the facility's quality system, particularly concerning aseptic processing controls, cleaning validation, personnel training, and facility design, all of which could impact product quality and patient safety.