# FDA 483 - Joe Wise Pharmacy, Inc. - May 23, 2017

Source: https://www.keypedia.com/records/483/joe-wise-pharmacy-inc/281838c0-f967-4977-9186-4dc68385f3cf

> FDA 483 for Joe Wise Pharmacy, Inc. on May 23, 2017. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Joe Wise Pharmacy, Inc.
- Inspection Date: 2017-05-23
- Product Type: Drugs
- Office Name: Denver District Office
- Summary: On May 23, 2017, the FDA issued a Form 483 to Joe Wise Pharmacy, Inc. in Littleton, CO, following an inspection from May 8-23, 2017. The firm is a producer of sterile and non-sterile drugs.

The inspection revealed several observations related to sterile drug production:

1.  **Non-Sterile Disinfecting Agents and Wipes:** Disinfecting agents and wipes used in the ISO 5 zone were not sterile. Specifically, wipes used with a sanitizing agent and a disinfectant used inside a biological safety cabinet were not sterile.
2.  **Non-Sterile Gloves:** Personnel engaged in aseptic processing were observed wearing non-sterile gloves. Additionally, a specific assembly within a biological safety cabinet was not identified as sterile, and no sporicidal treatment was performed on it prior to sterile drug production.
3.  **Lack of Pressure Differential Monitoring:** Pressure differentials between areas with different air classifications were not monitored. An instance was observed where a pharmacist cleaned equipment in an unclassified room and then replaced a refuse bag inside the ISO 5 zone, exposing the ISO 5 zone to unclassified air without pressure monitoring.
4.  **ISO 5 Area in Non-Classified Room:** The ISO 5 classified area, specifically a biological safety cabinet used for aseptic filling, was located within an unclassified room.
5.  **Sinks/

## Related Documents

- [483 - 2019-06-21](https://www.keypedia.com/records/483/joe-wise-pharmacy-inc/a7a02aa3-2727-422e-8be3-c8ad42fd3d47)
- [483 - 2019-06-21](https://www.keypedia.com/records/483/joe-wise-pharmacy-inc/449ef144-4178-44c2-a17d-caaf06986354)

## Related Officers

- [Jamie L. C. Dian](https://www.keypedia.com/people/jamie-l-c-dian/4104b6f7-4afe-4a9d-96cb-798b0fa1d37a)
- [Performance Improvement Coordinator](https://www.keypedia.com/people/tenzin-jangchup/733eb315-0eeb-40ce-af6d-03b406a9235d)
- [Jamie L. C. Dion](https://www.keypedia.com/people/jamie-l-c-dion/bea1370f-d56e-4eb1-8026-fcdec73d6eae)

Company: https://www.keypedia.com/companies/joe-wise-pharmacy-inc/8ac7a1f8-1732-45f7-bc24-3cd70f6e5b8a

Office: https://www.keypedia.com/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face