# FDA 483 - Empower Pharmacy - August 05, 2022

Source: https://www.keypedia.com/records/483/empower-pharmacy/9bf65219-464f-4017-bdc8-b3d1c2d47a28

> FDA 483 for Empower Pharmacy on August 05, 2022. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Empower Pharmacy
- Inspection Date: 2022-08-05
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: On August 5, 2022, the FDA issued a Form 483 to Empower Clinic Services LLC dba Empower Pharmacy, an outsourcing facility in Houston, TX, following an inspection from July 18 to August 5, 2022. The report, addressed to Chief Production Officer Pejmon Jonathan Abrarpour, detailed 17 observations regarding significant deficiencies in quality control, aseptic processing, environmental monitoring, cleaning, investigations, component control, laboratory controls, container/closure handling, product release, regulatory reporting, and labeling.

Key violations include the Quality Unit's failure to investigate complaints, deviations, and OOS results, report adverse events timely, and ensure API/excipient suitability. The firm lacked procedures for returning cleanrooms to operating conditions after shutdowns and failed to implement CAPAs, specifically regarding endotoxin testing for L-Citrulline. Aseptic processing areas were deficient in environmental monitoring, cleaning, and disinfection. The firm failed to thoroughly investigate discrepancies, including numerous complaints about unlabeled products and particulates in Coenzyme Q-10 Injection, and potency failures for Vitamin B-Complex Injection.

Further issues included inadequate procedures for in-process visual inspection, lack of AQL sampling, and insufficient documentation for component suitability, with several raw materials labeled "Not for Drug Use" or lacking proper testing/justification. Endotoxin limits for injectable products were not scientifically established. Container/closure sterilization processes lacked hold time studies and

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## Related Officers

- [Suzanne N. Vallez](https://www.keypedia.com/people/suzanne-n-vallez/7c16e0f4-c0b1-4f50-adfa-b1dc534694cd)
- [Margaret M. Annes](https://www.keypedia.com/people/margaret-m-annes/e528fbbe-2a4c-4697-9256-b7f2d0bcd279)

Company: https://www.keypedia.com/companies/empower-pharmacy/d0830ab6-58b6-4661-95a6-31c44f7c46fe

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c