Arta Shaun Noorian
Owner
Empower Clinic Services, LLC dba Empower Pharmacy
5980 West Sam Houston Parkway North
Suite 300
Houston , TX 77041-5251
United StatesFEI 3021758709Issued Oct 15, 2021Office of Pharmaceutical Quality Operations, Division II
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.
Violations3
Issue DateOct 15, 2021
Product TypeDrugs
StatusOpen
Letter Details
Firm
Empower Clinic Services, LLC dba Empower Pharmacy
Location
Arta Shaun Noorian
Owner
Empower Clinic Services, LLC dba Empower Pharmacy
5980 West Sam Houston Parkway North
Suite 300
Houston , TX 77041-5251
United States
FEI Number
3021758709
Country
United States
Issue Date
October 15, 2021
Issuing Office
Office of Pharmaceutical Quality Operations, Division II
Product Type
Drugs
Status
Open
Summary
Empower Pharmacy, a registered outsourcing facility, produced compounded 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 and labeling requirements. An FDA inspection conducted from February to March 2020 identified violations, though the specific compliance failures are not detailed in the provided excerpt. The company's response to the FDA Form 483 was received on March 27, 2020, but the products were deemed to violate the FDCA.
Empower Clinic Services, LLC dba Empower Pharmacy FDA Warning Letter, October 15, 2021
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