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 Pharma
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 Pharma, a registered outsourcing facility, was warned for producing adulterated drug products that failed to meet the conditions required under section 503B of the Federal Food, Drug, and Cosmetic Act to qualify for compounding exemptions. During an inspection from August through August 2024, FDA investigators identified serious deficiencies in the facility's practices for producing sterile drug products, including failures to comply with conditions necessary for outsourcing facility status, which put patients at risk. The company voluntarily recalled Pyridoxine HCL Injection Solution, 100mg/mL (lot 609763) in September 2024 following the inspection findings.
Empower Clinic Services, LLC dba Empower Pharma FDA Warning Letter, April 2, 2025
Talk to a Specialist