# FDA 483 - empower clinic services, llc,  - November 14, 2025

Source: https://www.keypedia.com/records/483/empower-clinic-services-llc/ce913383-fac3-4372-ad8f-94b794669a34

> FDA 483 for empower clinic services, llc,  on November 14, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: empower clinic services, llc, 
- Inspection Date: 2025-11-14
- Product Type: drugs
- Office Name: Dallas District Office
- Summary: The FDA inspected Empower Clinic Services, LLC dba Empower Pharmacy in Houston, TX, and issued a Form 483 with six observations. The inspection revealed significant deficiencies in aseptic processing, including microbial contamination, inadequate cleaning and disinfection, poor aseptic technique, disrupted unidirectional airflow, and insufficient smoke studies and media fills. These issues indicate a high risk of product contamination and compromise of sterile drug product quality.

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Company: https://www.keypedia.com/companies/empower-clinic-services-llc/3c4e9f1f-9b53-408d-8a8c-4d0d20481e0c

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