Empowered Diagnostics LLC
FDA inspection history in Pompano Beach, Florida, 2022
- 1
- Warning letter
- 1
- Form 483
Every document, by year
- Warning letter
- Form 483
2022: one warning letter and one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2022One warning letter and one Form 483, at Pompano Beach, Florida.
Cited most
Across all Empowered Diagnostics observations on file
- 21 CFR 820.100Corrective and preventive action1
- 21 CFR 820.198Complaint files1
- 21 CFR 820.30Design controls1
- 21 CFR 820.40Document controls1
- 21 CFR 820.50Purchasing controls1
The complete Empowered Diagnostics file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Pompano Beach, Florida
One warning letter and one Form 483 · 2022 · 6 observations
Latest: Warning letter, Oct 6, 2022 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-10-06 | Warning letter Warning letter | Pompano Beach, Florida | — | $99 |
| 2022-02-25 | 483 Form 483 | Pompano Beach, Florida | 6 | $99 |
Investigators on these documents
FEI number 3017977164 · most recent document Oct 6, 2022
About Empowered Diagnostics LLC
How many FDA Form 483s has Empowered Diagnostics LLC received?
FDA Intel has 1 Form 483 on file for Empowered Diagnostics LLC; the most recent is dated Feb 25, 2022.
When was Empowered Diagnostics LLC last inspected by FDA?
The most recent FDA inspection document on file for Empowered Diagnostics LLC is a Form 483 dated Feb 25, 2022, for the site in Pompano Beach, Florida.
What did FDA cite at Empowered Diagnostics LLC?
The regulations cited most in the observations on file for Empowered Diagnostics LLC are 21 CFR 820.100 (Corrective and preventive action), 1 time; 21 CFR 820.198 (Complaint files), 1 time; 21 CFR 820.30 (Design controls), 1 time.
Has Empowered Diagnostics LLC received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Empowered Diagnostics LLC; the most recent is dated Oct 6, 2022.