Arta Shaun Noorian
Chief Executive Officer
Empower Clinic Services, LLC dba Empower Pharma
5980 West Sam Houston Parkway North, Suite 300
Houston , TX 77041-5254
United StatesFEI 3021758709Issued Apr 2, 2025Center for Drug Evaluation and Research (CDER)
Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3021758709.
Violations7
Issue DateApr 2, 2025
Product TypeDrugs
StatusOpen
Letter Details
Firm
Empower Clinic Services, LLC dba Empower Pharmacy
Location
Arta Shaun Noorian
Chief Executive Officer
Empower Clinic Services, LLC dba Empower Pharma
5980 West Sam Houston Parkway North, Suite 300
Houston , TX 77041-5254
United States
FEI Number
3021758709
Country
United States
Issue Date
April 02, 2025
Issuing Office
Center for Drug Evaluation and Research (CDER)
Product Type
Drugs
Status
Open
Summary
Empower Pharmacy, a registered outsourcing facility, produced adulterated drug products that failed to meet the conditions required under section 503B of the Federal Food, Drug, and Cosmetic Act to qualify for exemptions from drug approval requirements. FDA investigators inspected the facility from August 1-28, 2024, and identified serious deficiencies in practices for producing drugs intended to be sterile, creating patient safety risks and violations of current good manufacturing practices. The company recalled Pyridoxine HCL Injection Solution (lot 609763) in September 2024 following the inspection findings.
Empower Clinic Services, LLC dba Empower Pharmacy FDA Warning Letter, April 2, 2025
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