Empower Clinic Services, LLC
Form 483 issued March 6, 2020 · Houston, Texas
- Inspection
- Feb 12 – Mar 6, 2020
- Investigator
- Camerson E. Moore
- Observations
- 6
- Pages
- 5
- FEI number
- 3011887629
In short: On March 6, 2020, FDA issued a Form 483 with 6 observations to Empower Clinic Services, LLC in Houston, Texas (FEI 3011887629) after an inspection that ran Feb 12 – Mar 6, 2020. The investigator was Camerson E. Moore. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Observations span 4 systems, led by production.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Aseptic processing areas are deficient regarding the system…
- 02
Time limits are not established when appropriate for the completion of each production phase to assure…
- 03
The responsibilities and procedures applicable to the quality control unit are not in…
- 04
Observation 4: scanned text, readable in the full document.
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 history
All 12 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Empower Clinic Services, LLC?
FDA listed 6 observations on this Form 483, mostly about production, facilities & equipment and quality system. 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?
Camerson E. Moore is named on this Form 483, for the inspection of Feb 12 – Mar 6, 2020. Each investigator has a profile showing what they cite most.
When was Empower Clinic Services, LLC inspected by FDA?
The inspection ran Feb 12 – Mar 6, 2020, and the Form 483 is dated March 6, 2020.
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.