Empower Clinic Services LLC dba Empower Pharma — FDA 483 Findings

There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specification whether or not the batch has been already distributed.

Your firm failed to establish an adequate system for cleaning and disinfecting the room and equipment to produce aseptic conditions Specifically, Per the firm's procedure B-SOP-STR-0004, titled "Cleaning and Disinfection of the Cleanroom", Revision 017, effective date 10/05/2025.

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed.

The written stability program for drug products does not include reliable, meaningful and specific test methods.

Control procedures are not established which monitor the output and validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.

The responsibilities and procedures applicable to the quality control unit are not fully followed.

Your firm failed to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality.

Time limits are not established when appropriate for the completion of each production phase to assure the quality of the drug product.

HEPA filters are not sealed around the perimeter.