Empower Clinic Services, LLC
Form 483 issued August 5, 2022 · Houston, Texas
- Inspection
- Jul 18 – Aug 5, 2022
- Investigators
- Margaret M. Annes· Suzanne N. Vallez
- Observations
- 17
- Pages
- 15
- FEI number
- 3011887629
In short: On August 5, 2022, FDA issued a Form 483 with 17 observations to Empower Clinic Services, LLC in Houston, Texas (FEI 3011887629) after an inspection that ran Jul 18 – Aug 5, 2022. The investigators were Margaret M. Annes and Suzanne N. Vallez. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Observations span 4 systems, led by quality system.
Most cited: 21 CFR 211.113(b) (2×)
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
- 03
EMPI.OYEE(S) SIGNATURE Aseptic processing areas are defi cient regarding the system for monitoring environmental conditions. Specifica…
- 04
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
This inspection in context
Margaret M. Annes
60 documents · 2007–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Texas.
The firmEmpower Clinic Services, LLC history
All 12 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Empower Clinic Services, LLC?
FDA listed 17 observations on this Form 483, mostly about quality system, production and facilities & equipment. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Empower Clinic Services, LLC?
Margaret M. Annes and Suzanne N. Vallez are named on this Form 483, for the inspection of Jul 18 – Aug 5, 2022. Each investigator has a profile showing what they cite most.
When was Empower Clinic Services, LLC inspected by FDA?
The inspection ran Jul 18 – Aug 5, 2022, and the Form 483 is dated August 5, 2022.
How do I get the full Form 483 for Empower Clinic Services, LLC?
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.