Criticare Technologies
FDA inspection history across 3 sites, 2017 to 2024
- 2
- Warning letters
- 1
- Form 483
Every document, by year
- Warning letter
- Form 483
2017: one warning letter; 2024: one warning letter and one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2017One warning letter, at North Kingstown, Rhode Island.
- 2024One warning letter and one Form 483, at Orlando, Florida and Warwick, Rhode Island.
Cited most
Across all Criticare Technologies observations on file
- 21 CFR 820.30(f)Design controls3
- 21 CFR 820.100(a)Corrective and preventive action1
- 21 CFR 820.198(a)Complaint files1
- 21 CFR 820.25(b)Personnel1
- 21 CFR 820.50Purchasing controls1
The complete Criticare Technologies file.
All 3 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
Orlando, Florida
One warning letter · 2024
Latest: Warning letter, Jul 12, 2024 →Warwick, Rhode Island
One Form 483 · 2024 · 10 observations
Latest: Form 483, May 10, 2024 →North Kingstown, Rhode Island
One warning letter · 2017
Latest: Warning letter, Apr 21, 2017 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-07-12 | Warning letter Warning letter | Orlando, Florida | — | $99 |
| 2024-05-10 | 483 Form 483 | Warwick, Rhode Island | 10 | $99 |
| 2017-04-21 | Warning letter Warning letter | North Kingstown, Rhode Island | — | $99 |
Investigators on these documents
FEI number 3012238587 · most recent document Jul 12, 2024
About Criticare Technologies
How many FDA Form 483s has Criticare Technologies received?
FDA Intel has 1 Form 483 on file for Criticare Technologies; the most recent is dated May 10, 2024.
When was Criticare Technologies last inspected by FDA?
The most recent FDA inspection document on file for Criticare Technologies is a Form 483 dated May 10, 2024, for the site in Warwick, Rhode Island.
What did FDA cite at Criticare Technologies?
The regulations cited most in the observations on file for Criticare Technologies are 21 CFR 820.30(f) (Design controls), 3 times; 21 CFR 820.100(a) (Corrective and preventive action), 1 time; 21 CFR 820.198(a) (Complaint files), 1 time.
Has Criticare Technologies received an FDA warning letter?
Yes. FDA Intel has 2 FDA warning letters on file for Criticare Technologies; the most recent is dated Jul 12, 2024.