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

Source: https://www.keypedia.com/records/483/pq-pharmacy-llc/9004bfc3-0b56-44dd-b90f-b2c44f6dd5ca

> FDA 483 for PQ Pharmacy LLC on October 27, 2022. Product: Devices. 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: Devices
- Office Name: Florida District Office
- Summary: On October 11-27, 2022, the FDA inspected PQ Pharmacy LLC, an outsourcing facility (503B) located at 15215 Technology Dr, Brooksville, FL 34604-0690. The inspection, led by Investigators Joanne E King and Kayla V Sprague, resulted in six observations detailed in Form 483, issued to President Hale N. Dimetry on November 17, 2022.

Key observations include:
1.  **Quality Control Unit Deficiencies:** The quality control unit (QCU) lacked authority to fully investigate errors and did not fully investigate laboratory test results before releasing finished drug products. Specifically, assay testing for Prednisolone Sodium Phosphate/Moxifloxacin HCL/Bromfenac 1%/0.5%/0.09% and Prednisolone Sodium Phosphate/Moxifloxacin HCL 1%/0.5% ophthalmic solutions was performed using an unvalidated test method, with lots distributed prior to method validation on October 27, 2022.
2.  **QCU Procedure Non-Adherence:** The QCU's responsibilities and procedures were not fully followed. The beyond use date (BUD) for Mitomycin (1mg/1ml) in 50 ml syringe was extended multiple times (from 60 to 90,

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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/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9