# FDA WARNING_LETTER - Empower Clinic Services, LLC dba Empower Pharmacy - March 06, 2020

Source: https://www.keypedia.com/records/warning_letter/empower-clinic-services-llc-dba-empower-pharmacy/557296ff-15da-4ea7-9194-c68d8a9ebbf1

> FDA WARNING_LETTER for Empower Clinic Services, LLC dba Empower Pharmacy on March 06, 2020. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Empower Clinic Services, LLC dba Empower Pharmacy
- Inspection Date: 2020-03-06
- Product Type: Drugs
- Office Name: Office of Pharmaceutical Quality Operations Division I
- Summary: On October 15, 2021, the FDA issued a Warning Letter to Empower Clinic Services, LLC dba Empower Pharmacy, an outsourcing facility registered under section 503B of the FDCA. The letter followed an inspection from February 12 to March 6, 2020, which revealed that drug products produced by the facility failed to meet 503B conditions, thus losing exemptions from drug approval, adequate directions for use, and Drug Supply Chain Security Act requirements.

Key violations included:
1.  **Labeling Deficiencies:** Several injectable drug products (e.g., HCG, Testosterone Cypionate) lacked required adverse event reporting information (www.fda.gov/medwatch and 1–800–FDA–1088) on their containers, violating Section 503B(a)(10) of the FDCA.
2.  **Incomplete Reporting:** The facility failed to submit complete drug product compounding reports in December 2019 and June 2020, as required by Section 503B(b)(2) of the FDCA.
3.  **Inadequate Adverse Event Reporting Procedures:** The facility's procedures for adverse event reporting were deficient, lacking requirements for prompt investigation and 15-day follow-up reports for serious, unexpected adverse events, violating Section 503B(b)(5) of

## Related Documents

- [WARNING_LETTER - 2024-08-28](https://www.keypedia.com/records/warning_letter/empower-clinic-services-llc-dba-empower-pharmacy/31515f8c-5824-4340-ad9a-24a69b1d4222)
- [WARNING_LETTER - 2024-10-04](https://www.keypedia.com/records/warning_letter/empower-clinic-services-llc-dba-empower-pharmacy/7e593e15-cb36-4894-b9fe-024b6fe570f4)

## Related Officers

- [Director of Investigations Branch](https://www.keypedia.com/people/tamala-p-bogan/af87cd07-1e38-459f-94a0-58b5bf5f533c)
- [Karen Tannert](https://www.keypedia.com/people/karen-tannert/c775a36b-39b7-4c1c-8a47-e8ee345f3918)

Company: https://www.keypedia.com/companies/empower-clinic-services-llc-dba-empower-pharmacy/4d843835-22e0-4371-93b8-0da9eb230a99

Office: https://www.keypedia.com/offices/office-of-pharmaceutical-quality-operations-division-i/798d6a62-d1f1-4f7c-8de3-465e277c13da