Empower Clinic Services, LLC dba Empower Pharma
Empower Clinic Services, LLC dba Empower Pharma, a 503B outsourcing facility in Houston, TX, received an FDA Warning Letter citing adulterated and misbranded sterile drug products — including Testosterone Cypionate, Glutathione, Pyridoxine HCl, and Lipo-B injections — due to serious CGMP deficiencies in aseptic processing, inadequate environmental monitoring, and failure to meet 503B labeling conditions. The facility released batches despite positive microbial contamination findings, failed to conduct adequate smoke studies, and had repeat violations previously discussed at a May 2023 regulatory meeting. Because the compounded products did not meet all 503B conditions, they are subject to unapproved new drug and misbranding violations under the FDCA. FDA warned that failure to adequately address violations may result in seizure and injunction.
Flagged claims (5)
drug products produced by your facility failed to meet the conditions of section 503B
their labeling fails to bear adequate directions for their intended uses causing them to be misbranded under section 502(f)(1) of the FDCA
Pyridoxine HCl (B6) Injection Solution, did not include the following information on the container: 1) information to facilitate adverse event reporting: www.fda.gov/medwatch and 1-800-FDA-1088 and 2) directions for use, including, as appropriate, dosage and administration
You do not have any FDA-approved applications on file for drug products that you compound.
drug products intended or expected to be sterile were prepared, packed, or held under insanitary conditions, whereby they may have become contaminated with filth or rendered injurious to health
Required actions (3)
Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to address any violations.
FDA strongly recommends that your management undertake a comprehensive assessment of operations, including facility design, procedures, personnel, processes, maintenance, materials, and systems. In particular, this review should assess your aseptic processing operations. A third-party consultant with relevant sterile drug manufacturing expertise should assist you in conducting this comprehensive evaluation.
Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.
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