West Coast Nuclear Pharmacy – FDA Warning Letter, Mar 23, 2018

On October 6, 2020, the FDA issued a Warning Letter to West Coast Nuclear Pharmacy, LLC, following an inspection from March 19-23, 2018. The inspection revealed serious deficiencies in sterile drug product production, leading to adulterated drug products under FDCA Section 501(a)(2)(A).

Key violations included: 1. **Microbial contamination** in the ISO 5 area during aseptic production without adequate evaluation or action. 2. Use of **non-sterile disinfecting agents and materials** in the ISO 5 area. 3. **Unclassified air influx** into the ISO 7 buffer room due to the location of (b)(4). 4. **Poor aseptic practices**, such as employees touching non-sterile objects (e.g., buffer room door) and then performing aseptic manipulations without changing or sanitizing gloves. 5. Placement of **non-sterile (b)(4)** within the ISO 5 hood during aseptic processing.

The FDA found the firm's corrective actions deficient. For instance, the sporicidal contact time for disinfectant was insufficient, revised SOPs did not consistently reflect commitments, and the use of non-sterile disinfectants followed by sterile ones was deemed ineffective. Smoke studies for air ingress were static and lacked continuous pressure monitoring. Glove sanitation procedures were also inadequate.

The FDA strongly recommended a comprehensive assessment of operations by a third-party consultant.