FDA 483 - Eagle Pharmacy, Inc - August 21, 2015

This FDA Form 483 details numerous deficiencies observed during an inspection of an outsourcing facility.

**Key Violations and Observations:**

* **Quality System Failures:** * Failure to thoroughly review batch failures: Two injectable drug products were released and distributed despite failing potency tests. * Lack of established, written, and followed procedures to prevent microbiological contamination of sterile drug products. * Inadequate validation for sterilization processes: A specific sterilization process for injectable drug suspensions was not supported by validation data for a particular product (methylprednisolone). * Lack of calibration documentation for equipment (REDACTED used for REDACTED). * No stability data to support the 180-day expiration date assigned to all injectable drug products. * Laboratory controls lack scientifically sound and appropriate test procedures; injectable drug products are not tested using validated methods.

* **Aseptic Processing and Environmental Control Deficiencies:** * **Contamination Risks:** * Bulk Ketorolac Tromethamine was left uncovered during transfer and filling in the ISO 5 compounding room. * Operator practices during compounding: arm moving over sterile vials, hands dropping below airflow, resting on critical surfaces, and handling outside objects without re-sanitization. * Materials transferred to critical work surface without sanitization. * **Airflow and Facility Design:** *