joe wise pharmacy, inc., – FDA Warning Letter, Jun 21, 2019

On April 15, 2021, the FDA issued a Warning Letter to Joe Wise Pharmacy, Inc. dba Wise Pharmacy, following an inspection from June 12-21, 2019. The inspection revealed serious deficiencies in the production of sterile and non-sterile drug products, leading to adulterated products under FDCA Section 501(a)(2)(A).

Key violations included: 1. **Insanitary Conditions:** The ISO 5 workstation for sterile products was located and operated in a non-classified area, where non-sterile compounding also occurred. 2. **Contamination Risks:** The non-classified room with the ISO 5 workstation contained a sink and dishwasher, potential microbial contamination sources. 3. **Inadequate Cleaning:** Hazardous drug hoods were cleaned only with (b)(4), failing to adequately deactivate hazardous drugs and posing cross-contamination risks. 4. **Water Quality:** Failure to confirm water quality suitability for non-sterile drug production. 5. **Airflow Deficiencies:** Inadequate smoke studies under dynamic conditions to demonstrate unidirectional airflow in the ISO 5 area. 6. **Environmental Monitoring:** Routine environmental monitoring samples from ISO 5 surfaces were incubated at uncontrolled room temperature.

The firm initiated a voluntary recall of all sterile drug products and ceased sterile compounding on July 10, 2019. While some corrective actions were acknowledged,