# FDA 483 - PQ Pharmacy LLC - October 27, 2022

Source: https://www.keypedia.com/records/483/pq-pharmacy-llc/361213ab-b245-4a48-b2f4-e6d11d817460

> FDA 483 for PQ Pharmacy LLC on October 27, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: PQ Pharmacy LLC
- Inspection Date: 2022-10-27
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: PQ Pharmacy LLC, an outsourcing facility in Brooksville, FL, was cited for significant quality control and compliance issues during an FDA inspection. The firm failed to validate test methods, properly investigate out-of-specification results, and adhere to established hold times and stability programs for drug products. Additionally, the facility did not submit required reports to the FDA identifying compounded drugs.

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## Related Officers

- [Pharmaceutical Investigator](https://www.keypedia.com/people/kayla-v-sprague/154cb543-111b-4ad1-b45b-43900df71b90)
- [Special Assistant](https://www.keypedia.com/people/joanne-e-king/39af2e60-385c-4023-a977-a25157b25563)

Company: https://www.keypedia.com/companies/pq-pharmacy-llc/313f1896-4cac-4c1b-b4da-5cbc8bd8893d

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6