Empowered Diagnostics LLC
Form 483 issued February 25, 2022 · Pompano Beach, Florida
- Inspection
- Feb 3 – Feb 25, 2022
- Investigators
- Gisselle I. Sensebe· Stanley B. Eugene
- Observations
- 6
- Pages
- 12
- FEI number
- 3017977164
In short: On February 25, 2022, FDA issued a Form 483 with 6 observations to Empowered Diagnostics LLC in Pompano Beach, Florida (FEI 3017977164) after an inspection that ran Feb 3 – Feb 25, 2022. The investigators were Gisselle I. Sensebe and Stanley B. Eugene. Most observations concern cAPA and production & process controls.
At a glance
CAPA and production & process controls account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures for design control…
- 02
Procedures for collective and preventive action have…
- 03
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have…
- 04
Procedures for finished device acceptance have…
This inspection in context
Gisselle I. Sensebe
3 documents · 2022–2026
Cites 820.100 (corrective and preventive action) more than any other section. Most of their documents are for sites in Florida.
The firmEmpowered Diagnostics LLC history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.30
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Empowered Diagnostics LLC?
FDA listed 6 observations on this Form 483, mostly about cAPA, production & process controls and design controls. The opening words of each observation are shown on this page.
Who inspected Empowered Diagnostics LLC?
Gisselle I. Sensebe and Stanley B. Eugene are named on this Form 483, for the inspection of Feb 3 – Feb 25, 2022. Each investigator has a profile showing what they cite most.
When was Empowered Diagnostics LLC inspected by FDA?
The inspection ran Feb 3 – Feb 25, 2022, and the Form 483 is dated February 25, 2022.
How do I get the full Form 483 for Empowered Diagnostics 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.