# FDA 483 - Empower Pharmacy - March 06, 2020

Source: https://www.globalkeysolutions.net/records/483/empower-pharmacy/b6a56445-8175-421b-8116-b5fee1566e6b

> FDA 483 for Empower Pharmacy on March 06, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Empower Pharmacy
- Inspection Date: 2020-03-06
- Product Type: drugs
- Office Name: Dallas District Office
- Summary: Empower Clinic Services, LLC, an outsourcing facility in Houston, TX, was cited for significant deficiencies during an FDA inspection. Observations included inadequate environmental monitoring in aseptic processing, failure to establish validated hold-times for sterile drug products, and a lack of adherence to quality control unit procedures. The firm was also found to be compounding drugs that are essentially copies of approved drugs, failing to include required adverse event reporting information on container labels, and not submitting adverse event reports to the FDA.

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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