FDA 483 - Park Avenue Compounding - February 08, 2024

This FDA Form 483 details ten observations from an inspection of an outsourcing facility.

**Facility and Operations:** The facility compounds various drug products, including Morphine Sulfate, Fentanyl, Ropivacaine, and penicillin/beta-lactam products.

**Violations and Observations:**

1. **Production and Process Controls:** Failure to establish written procedures for production and process controls. Two potency failures for Morphine Sulfate 50 mg in 50 mL of NS (1 mg/mL) were observed (206.5% and 76.0%). Interim CAPA was ineffective, and new batch steps were undocumented. Process validation for Morphine Sulfate was not performed. 2. **Aseptic Processing Area Monitoring:** Deficient environmental monitoring. Active viable monitoring is only performed after production, with questionable device placement. Non-Viable Particle (NVP) monitoring locations are inconsistent. Settle plate placement was observed to be directly behind a spray bottle, potentially inhibiting microbial growth. Surface sampling is limited to one area. Production technician monitoring lacks scientific justification for frequency and acceptance limits, with some samples held to ISO 7 standards instead of ISO 5. 3. **Penicillin Processing:** Operations for penicillin and beta-lactam products were performed in the same hood used for other drug products, with numerous instances documented in 2022 and 2023. 4. **Expiration Dating:** Stability