FDA WARNING_LETTER - Empower Clinic Services, LLC dba Empower Pharmacy - August 28, 2024

On April 2, 2025, the FDA issued Warning Letter #700962 to Empower Pharma, an outsourcing facility registered under section 503B of the FDCA. The letter followed an inspection from August 1 to August 28, 2024, which revealed serious deficiencies in the production of sterile drug products, putting patients at risk.

The FDA noted that Empower Pharma's drug products, including Pyridoxine HCl (B6) Injection Solution, failed to meet 503B conditions, specifically lacking adverse event reporting information and adequate directions for use on labels. This renders the products ineligible for exemptions from FDA approval, adequate directions for use, and Drug Supply Chain Security Act requirements.

Violations included adulterated drug products due to insanitary conditions and CGMP failures. Examples cited were inadequate product evaluation after microbial contamination in the ISO 5 aseptic area, failure to perform adequate dynamic smoke studies, and lack of appropriate written procedures for preventing microbiological contamination (21 CFR 211.113(b)). The firm also failed to thoroughly investigate discrepancies (21 CFR 211.192), maintain aseptic equipment (21 CFR 211.42(c)(10)(vi)), monitor environmental conditions (21 CFR 211.42(c)(10)(iv)), and establish adequate production and process controls (21 CFR 21