# FDA WARNING_LETTER - joe wise pharmacy, inc.,  - June 21, 2019

Source: https://www.keypedia.com/records/warning_letter/joe-wise-pharmacy-inc/2c26d6bb-8a34-4a53-bc77-196f83687315

> FDA WARNING_LETTER for joe wise pharmacy, inc.,  on June 21, 2019. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: joe wise pharmacy, inc., 
- Inspection Date: 2019-06-21
- Product Type: Drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: 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,

## Related Officers

- [Director - Compliance Branch](https://www.keypedia.com/people/lance-m-de-souza/8445cae5-3104-4159-89e9-e07fb7852270)

Company: https://www.keypedia.com/companies/joe-wise-pharmacy-inc/9adafb68-9774-4b0a-a222-1031e1a0c703

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6