FDA 483 - Davis City Pharmacy Inc. - February 18, 2022

During an FDA inspection from February 15-18, 2022, Davis City Pharmacy Inc., a producer of non-sterile drug products located at 111 Trinity St, Weatherford, TX, was cited for five observations. The inspection was issued to Brandi M. Chane-Lee, Owner/Certified Pharmacy Technician.

**Key Observations:**

1. **Inadequate Containment and Cleaning for Potent Drugs:** The firm produced highly potent and/or hazardous non-sterile drug products (creams and capsules containing hormones like Progesterone or Testosterone) on an open countertop without adequate containment, segregation, or proper cleaning procedures. A spill of Testosterone was observed, and the cleaning agent used (b)(4) lacked scientific justification for deactivating or decontaminating the hazard. The firm also used a non-pharmaceutical grade liquid detergent, (b)(4), for cleaning equipment, which is not scientifically justified for inactivating or removing potent/hazardous drug substances.

2. **Unsealed Ceiling Tiles:** Loose, unsealed ceiling tiles with exposed wires were observed in the non-sterile "compounding lab" during drug preparation.

3. **Lack of Final Product Testing:** The firm failed to conduct appropriate tests to determine the identity and strength of active ingredients in non-sterile drug products, specifically Benzocaine 20%, Lidocaine 10%, Tetracaine 10% Lot #09302