FDA 483 - Lynn Oaks Compounding Pharmacy - April 15, 2022

On April 15, 2022, the FDA issued a Form 483 to Lynn Oaks Compounding Pharmacy in Thousand Oaks, CA, following an inspection from March 30 to April 15, 2022. The inspection revealed seven observations related to the facility's compounding practices and quality control.

**Key Observations:**

1. **Inadequate Containment and Cleaning for Hazardous Drugs:** The pharmacy produced hazardous/highly potent non-sterile drugs (e.g., digoxin, chlorambucil, tacrolimus, zonisamide, tretinoin, hormones) without adequate containment, cleaning of work surfaces, or utensils to prevent cross-contamination. Specifically, a technician spilled Zonisamide powder, cleaned surfaces with non-pharmaceutical grade dish detergent and alcohol without assurance of decontamination, and failed to clean interior surfaces of balance doors and counters between productions. Dirty plastic baskets used for cleaned utensils were also observed.

2. **Use of Non-Pharmaceutical Grade Components:** The firm used Analytical Standard Digoxin as an active pharmaceutical ingredient for patient-specific prescriptions and filtered water (not pharmaceutical grade) in all water-containing drug products.

3. **Vermin in Production Area:** A living insect was observed crawling on the exterior of the biological safety cabinet in the "compounding room," which was often open to the retail pharmacy area when non-hazardous drugs were produced.

4. **Lack of Microbiological