Empower Clinic Services, LLC dba Empower
Form 483 issued October 4, 2024 · Hou s ton, Texas
- Inspection
- Sep 24 – Oct 4, 2024
- Investigators
- Demario L. Walls· Saundrea A. Munroe
- Observations
- 8
- Pages
- 7
- FEI number
- 3021758709
In short: On October 4, 2024, FDA issued a Form 483 with 8 observations to Empower Clinic Services, LLC dba Empower in Hou s ton, Texas (FEI 3021758709) after an inspection that ran Sep 24 – Oct 4, 2024. The investigators were Demario L. Walls and Saundrea A. Munroe.
What FDA observed
Preview: the opening words of each observation- 01FDCA 501(a)(2)(A)
Hazardous drugs were produced without providing adequate containment, segregation, and/or cleaning of work surfaces, utensils, and/or…
- 02FDCA 501(a)(2)(A)
Production areas have difficult to clean or contain porous, particle generating, or visibly…
- 03FDCA 501(a)(2)(A)
Lack of routine certification ofthe ISO 5 area…
- 04FDCA 501(a)(2)(A)
Failure to appropriately and regularly clean and disinfect or sterilize equipment located in…
This inspection in context
Demario L. Walls
18 documents · 2020–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Texas.
The firmEmpower Clinic Services, LLC dba Empower history
All 6 documents on file for this site, in date order, with what was cited at each inspection.
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Questions about this 483
What did FDA find at Empower Clinic Services, LLC dba Empower?
FDA listed 8 observations on this Form 483. The opening words of each observation are shown on this page.
Who inspected Empower Clinic Services, LLC dba Empower?
Demario L. Walls and Saundrea A. Munroe are named on this Form 483, for the inspection of Sep 24 – Oct 4, 2024. Each investigator has a profile showing what they cite most.
When was Empower Clinic Services, LLC dba Empower inspected by FDA?
The inspection ran Sep 24 – Oct 4, 2024, and the Form 483 is dated October 4, 2024.
How do I get the full Form 483 for Empower Clinic Services, LLC dba Empower?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.