Empower Clinic Services, LLC
Form 483 issued November 25, 2015 · Houston, Texas
- Inspection
- Nov 25, 2015
- Investigators
- Latorie S. Jones· Stephen D. Brown
- Observations
- 7
- Pages
- 5
- FEI number
- 3011887629
In short: On November 25, 2015, FDA issued a Form 483 with 7 observations to Empower Clinic Services, LLC in Houston, Texas (FEI 3011887629) after an inspection that ran Nov 25, 2015. The investigators were Latorie S. Jones and Stephen D. Brown. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and quality system account for 5 of 7 observations.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review the failure of a batch or any of its…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…
- 03
Aseptic processing areas are deficient regarding the system…
- 04
There is no written testing program designed to assess the…
This inspection in context
Latorie S. Jones
21 documents · 2015–2024
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Arkansas.
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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Empower Clinic Services, LLC?
FDA listed 7 observations on this Form 483, mostly about facilities & equipment, quality system and production. 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?
Latorie S. Jones and Stephen D. Brown are named on this Form 483, for the inspection of Nov 25, 2015. Each investigator has a profile showing what they cite most.
When was Empower Clinic Services, LLC inspected by FDA?
The inspection ran Nov 25, 2015, and the Form 483 is dated November 25, 2015.
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.