Firm Record

Empower Clinic Services, LLC dba Empower Pharmacy findings history

30 findings from 4 inspection documents published by regulators. Each row below says what its date means.

US FDA 2021-10-26 ~ 2025-12-18 4 documents 30 findings

Areas cited

Aseptic processing and sterility assuranceEquipment and facilityProcess validationTraining and personnelRegulatory reporting and change controlOther quality systemLaboratory and QC controlsContamination controlMaterial and supplier controlDeviation, CAPA, and investigationLabeling and packagingQuality unit oversightEnvironmental monitoring

Published inspection documents

2025-12-18 US FDA 5 findingsEquipment and facility · Contamination control · Training and personnel · Aseptic processing and sterility assurance Failure to appropriately and regularly clean and disinfect or sterilize equipment located in the ISO <Redacted B4> area. 2025-04-29 US FDA 6 findingsEquipment and facility · Aseptic processing and sterility assurance · Environmental monitoring Your firm failed to appropriately sterilize equipment located in the ISO 5 area. Specifically, your firm did not sterilize the stopper sorting bowl, supply hopper, and insertion station that come into contact with stoppers used in the production of injectable drug products. Under section 301(a) of the FDCA [21 U.S.C. § 331(a)], the introduction or delivery for introduction into interstate commerce of any drug that is adulterated is a prohibited act. Further, it is a prohibited act under section 301(k) of the FDCA [21 U.S.C. § 331(k)] to do any act with respect to a drug if such act is done while the drug is held for sale after shipment in interstate commerce and results in the drug being adulterated. C. Corrective Actions We have reviewed your firm’s responses to the Form FDA 483. Regarding your response related to the insanitary conditions, some of your corrective actions appear adequate; however, we cannot fully evaluate the adequacy of the following corrective actions described in your response because you did not include sufficient information or supporting documentation… 2022-10-11 US FDA 15 findingsAseptic processing and sterility assurance · Other quality system · Material and supplier control · Regulatory reporting and change control · Labeling and packaging · Quality unit oversight · Laboratory and QC controls · Process validation · Deviation, CAPA, and investigation Aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic conditions. 2021-10-26 US FDA 4 findingsEquipment and facility Your facility did not submit adverse event reports to FDA in accordance with the content and format requirements established through guidance or regulation under section 310.305 of title 21, Code of Federal Regulations. 3 Specifically, your facility’s procedures for reporting adverse events are inadequate. For example, your documented procedures for reporting adverse events do not include a requirement to promptly investigate and submit a follow-up report regarding a serious, unexpected adverse event within 15 calendar days of receipt of new information or as requested by FDA. [Section 503B(b)(5) of the FDCA [21 U.S.C. §353b(b)(5)]; 21 CFR 310.305(c)(2)].

About this page

This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.

What is included. As of 2026-09-03, only documents that have a detail page (at least 3 findings) are listed. The company may have more documents; the full set is available in Company lookup below.

Companies are grouped by a normalised key, not the displayed name — “… Limited” and “… Ltd.” count as the same company. Translation and classification are automated and may differ in nuance from the source; the basis for judgement is always the regulator's published document.

Full history of Empower Clinic Services, LLC dba Empower Pharmacy — including inspection classifications Browse by document Go to Findings search