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

Source: https://www.keypedia.com/records/483/pq-pharmacy-llc/4636c4bb-66b9-4458-87f5-164441664f29

> 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: Florida District Office
- Summary: This FDA Form 483 document details observations made during an inspection of PQ Pharmacy LLC, an Outsourcing Facility (503B), located at 15215 Technology Dr, Brooksville, FL 34604-0690. The inspection was conducted from October 11, 2022, to October 27, 2022. The report was issued to Hale N. Dimetry, President.

A key observation relates to the Quality System, specifically the quality control unit (QCU). The QCU was found to lack the authority to adequately review production records for errors and fully investigate errors that occurred. Furthermore, the QCU did not fully investigate laboratory test results prior to releasing finished drug products.

A specific deficiency highlighted was the absence of a validated test method for assay testing of Prednisolone Sodium Phosphate/Moxifloxacin HCL/Bromfenac 1%/0.5%/0.09% and Prednisolone Sodium Phosphate/Moxifloxacin HCL 1%/0.5% ophthalmic solutions. Lot [redacted] was used for test method validation on [redacted], but prior to October 27, 2022, several lots of these ophthalmic solutions were distributed to customers with final assay results obtained using an unvalidated test method. These include lot [redacted] (8.6mL, [redacted] units

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## Related Officers

- [Pharmaceutical Investigator](https://www.keypedia.com/people/kayla-v-sprague/154cb543-111b-4ad1-b45b-43900df71b90)
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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