Empower Clinic Services, LLC
Form 483 issued January 24, 2018 · Houston, Texas
- Inspection
- Jan 10 – Jan 24, 2018
- Investigators
- Jason R. Caballero· Sha'tina Alridge
- Observations
- 1
- Pages
- 1
- FEI number
- 3011887629
In short: On January 24, 2018, FDA issued a Form 483 with 1 observation to Empower Clinic Services, LLC in Houston, Texas (FEI 3011887629) after an inspection that ran Jan 10 – Jan 24, 2018. The investigators were Jason R. Caballero and Sha'tina Alridge. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly investigate any unexplained discrepancy or failure of a batch, regardless…
This inspection in context
Jason R. Caballero
26 documents · 2014–2020
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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Empower Clinic Services, LLC?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Empower Clinic Services, LLC?
Jason R. Caballero and Sha'tina Alridge are named on this Form 483, for the inspection of Jan 10 – Jan 24, 2018. Each investigator has a profile showing what they cite most.
When was Empower Clinic Services, LLC inspected by FDA?
The inspection ran Jan 10 – Jan 24, 2018, and the Form 483 is dated January 24, 2018.
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.