Empower Clinic Services, LLC dba Empower
Form 483 issued December 1, 2023 · Houston, Texas
- Inspection
- Oct 16 – Dec 1, 2023
- Investigators
- Camerson E. Moore· Demario L. Walls
- Observations
- 8
- Pages
- 8
- FEI number
- 3021758709
In short: On December 1, 2023, FDA issued a Form 483 with 8 observations to Empower Clinic Services, LLC dba Empower in Houston, Texas (FEI 3021758709) after an inspection that ran Oct 16 – Dec 1, 2023. The investigators were Camerson E. Moore and Demario L. Walls. Most observations concern materials; the most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures).
At a glance
Observations span 1 system, led by materials.
Most cited: FDCA 501(a)(2)(A) (7×) · 211.84 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01FDCA 501(a)(2)(A)
Personnel were observed conducting aseptic manipulations where the movement of "first air" in the ISO 5…
- 02FDCA 501(a)(2)(A)
Personnel infrequently changed and sanitized…
- 03
Use of ingredients not intended for phaim aceutical use…
- 04FDCA 501(a)(2)(A)
Failure to appropriately and regularly clean and disinfect or sterilize equipment located in…
This inspection in context
Camerson E. Moore
48 documents · 2014–2026
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.
Similar 483sOther sites cited under 211.84
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Empower Clinic Services, LLC dba Empower?
FDA listed 8 observations on this Form 483, mostly about materials. The most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures). The opening words of each observation are shown on this page.
Who inspected Empower Clinic Services, LLC dba Empower?
Camerson E. Moore and Demario L. Walls are named on this Form 483, for the inspection of Oct 16 – Dec 1, 2023. Each investigator has a profile showing what they cite most.
When was Empower Clinic Services, LLC dba Empower inspected by FDA?
The inspection ran Oct 16 – Dec 1, 2023, and the Form 483 is dated December 1, 2023.
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.