Empower Clinic Services, LLC
Form 483 issued August 28, 2024 · Houston, Texas
- Inspection
- Aug 1 – Aug 28, 2024
- Investigators
- Dogbeda F. Mackenzie· Taichun Qin
- Observations
- 9
- Pages
- 11
- FEI number
- 3011887629
In short: On August 28, 2024, FDA issued a Form 483 with 9 observations to Empower Clinic Services, LLC in Houston, Texas (FEI 3011887629) after an inspection that ran Aug 1 – Aug 28, 2024. The investigators were Dogbeda F. Mackenzie and Taichun Qin. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Observations span 4 systems, led by facilities & equipment.
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
- 02
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 03
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures…
- 04
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Dogbeda F. Mackenzie
14 documents · 2021–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in California.
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 9 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?
Dogbeda F. Mackenzie and Taichun Qin are named on this Form 483, for the inspection of Aug 1 – Aug 28, 2024. Each investigator has a profile showing what they cite most.
When was Empower Clinic Services, LLC inspected by FDA?
The inspection ran Aug 1 – Aug 28, 2024, and the Form 483 is dated August 28, 2024.
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.