Empower Clinic Services, LLC dba Empower Pharma — FDA Warning Letter Findings

Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192).

Cleaning validation (CV) for multiple product contact equipment used in compounding implantable Testosterone and Estradiol pellets has not been completed although it appears that your firm continues to produce these products. You state you have already initiated the process of performing CV on the affected equipment prior to the inspection, but that (b)(4) . Your response did not provide any type of risk assessment for this gap nor state if your firm has any plans to stop…

Your firm failed to perform adequate smoke studies under dynamic conditions to demonstrate unidirectional airflow within the ISO 5 area. Therefore, your products intended to be sterile are produced in an environment that may not provide adequate protection against the risk of contamination. FDA investigators also noted CGMP violations at your facility, that caused your drug products to be adulterated within the meaning of section 501(a)(2)(B) of the FDCA. The violations include, for example…

You did not perform adequate product evaluation and take appropriate corrective action after microbial contamination was recovered within the ISO 5 aseptic processing area.

Your firm’s investigation of EM out of specification (OOS) results during aseptic batch processing was inadequate. The investigators noted that a fungus, Rhodotorula bacarum , was identified on fingertip samples from an operator during the filling operations on May 4, 2023, of Lipo-B/Methionine/Choline Chloride/Cyanocobalamin 25/50/1 mg/mL, lot (b)(4) . Your firm investigated this issue under non-conformance (NC)-000518, but did not determine a definitive root cause. The…

Our investigators observed discolored stains and scratches inside both of your ISO 5 LAFHs on August 12, 2024. Your response stated, “the insufficient maintenance of these areas at the time of inspection represented a deviation from established procedures and enhancements to Empower’s program for preventive maintenance of the classified area.” We acknowledge the pictures you provided showing maintenance was performed on the ISO 5 LAFHs based on the cleaning chemical that was…

Your firm failed to establish an adequate system for maintaining equipment used to control the aseptic conditions (21 CFR 211.42(c)(10)(vi)).

Your firm failed to establish written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(a)). Outsourcing facilities must comply with CGMP requirements under section 501(a)(2)(B) of the FDCA. FDA’s regulations regarding CGMP requirements for the preparation of drug products have been established in 21 CFR parts 210…

Your firm released a batch of a drug product intended to be sterile even though positive microbial growth was detected during environmental monitoring (EM) within the ISO 5 production area. You did not provide an adequate product impact assessment for Pyridoxine HCL lot 609763 compounded on April 18, 2024, when our investigators identified the observation during the inspection. As noted above, we acknowledge your recall of this lot on September 5, 2024. Your response stated…

Your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes (21 CFR 211.113(b)).

Your firm exceeded your action level of non-viable particles in the ISO 5 hood during the production of Ascorbic Acid Preserved 500 mg/mL Injection 30 mL lot (b)(4) filled on June 17, 2024. The (b)(4) system (b)(4) counter recorded a total plate count (TPC) that exceeded the action level for particles greater than or equal to (b)(4) microns, according to your internal specification. Your investigation stated the likely contributing factor to the failure was the machine or…

Our investigators observed 6-inch horizontal gaps below the back wall of the ISO 5 LAFH and the bar holes on the side wall of the ISO 5 E2150 LAFH. Your smoke study from June 26, 2023, was not conducted under dynamic conditions to demonstrate unidirectional airflow to include the impact of the gaps and bar holes on your aseptic process in your ISO 5 LAFHs, and to show that airflow could exit through the gaps in the back wall, which could prevent airflow from the ISO 7 cleanroom from entering the ISO 5 LAFH. We acknowledge that you executed an addendum to the original protocol and provided a summary table within document number B-REP-QAL-0168. However, your response did not include an executed protocol per B-PROT-QAL-0069 with documentation completed nor a video with your visual airflow study for review. Your response also lacked an assessment on product impact on lots within expiry made since the smoke study was performed to mitigate any potential concerns until your addendum was completed.

Your firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas (21 CFR 211.42(c)(10)(iv)).