# FDA 483 - Empower Pharmacy - November 25, 2015

Source: https://www.globalkeysolutions.net/records/483/empower-pharmacy/752229d6-e3cf-4878-8677-5e69e295e5e0

> FDA 483 for Empower Pharmacy on November 25, 2015. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Empower Pharmacy
- Inspection Date: 2015-11-25
- Product Type: drugs
- Office Name: Dallas District Office
- Summary: An FDA inspection of Empower Clinic Services, LLC in Houston, TX, a producer of sterile drug products, revealed significant deficiencies in their manufacturing processes. The firm failed to thoroughly investigate non-sterile batches, lacked adequate validation for sterilization processes, and exhibited shortcomings in environmental monitoring. Additionally, issues were noted with equipment maintenance, cleaning procedures, and the absence of a written stability testing program for drug products.

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## Related Officers

- [Consumer Safety Officer at Commissioned Corps of the U.S. Public Health Service](https://www.globalkeysolutions.net/people/latorie-s-jones/086d0897-7d63-4fa8-bdce-f1d17885abd7)
- [Principal Consultant](https://www.globalkeysolutions.net/people/stephen-d-brown/01ff1439-f6d7-4501-a104-573dae30d306)

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

Office: https://www.globalkeysolutions.net/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9