# Wise Pharmacy – FDA 483, Jun 21, 2019

Source: https://www.keypedia.com/records/483/wise-pharmacy/a7a02aa3-2727-422e-8be3-c8ad42fd3d47

> FDA 483 for Wise Pharmacy on June 21, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Wise Pharmacy
- Inspection Date: 2019-06-21
- Product Type: drugs
- Office Name: Denver District Office
- Summary: An FDA inspection of Joe Wise Pharmacy, Inc. DBA Wise Pharmacy in Littleton, CO, a producer of sterile and non-sterile drug products, revealed significant deficiencies in aseptic processing, hazardous drug handling, and environmental controls. Repeat observations from a previous inspection highlighted issues with the classification of aseptic areas and the presence of sinks in cleanrooms. The firm also failed to use pharmaceutical grade water and adequately monitor its aseptic processing environment.

## Related Documents

- [483 - 2017-05-23](https://www.keypedia.com/records/483/wise-pharmacy/281838c0-f967-4977-9186-4dc68385f3cf) — date: May 23, 2017

## Related Officers

- [Jamie L. C. Dion](https://www.keypedia.com/people/jamie-l-c-dion/bea1370f-d56e-4eb1-8026-fcdec73d6eae)

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

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