Criticare Technologies
Form 483 issued May 10, 2024 · Warwick, Rhode Island
- Inspection
- Mar 21 – May 10, 2024
- Investigator
- Sara M. Onyango
- Observations
- 10
- Pages
- 11
- FEI number
- 3012238587
In short: On May 10, 2024, FDA issued a Form 483 with 10 observations to Criticare Technologies in Warwick, Rhode Island (FEI 3012238587) after an inspection that ran Mar 21 – May 10, 2024. The investigator was Sara M. Onyango. Most observations concern cAPA and design controls; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
CAPA and design controls account for 6 of 10 observations.
Most cited: 21 CFR 820.30(g) (2×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures for collective and preventive action have…
- 02
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have…
- 03
Risk analysis is…
- 04
Design verification does not confirm that design output…
This inspection in context
Sara M. Onyango
9 documents · 2019–2026
Cites 820.30(f) (design controls) more than any other section. Most of their documents are for sites in Massachusetts.
The firmCriticare Technologies history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.30(g)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Criticare Technologies?
FDA listed 10 observations on this Form 483, mostly about cAPA, design controls and production & process controls. The most-cited regulation is 21 CFR 820.30 (design controls). The opening words of each observation are shown on this page.
Who inspected Criticare Technologies?
Sara M. Onyango is named on this Form 483, for the inspection of Mar 21 – May 10, 2024. Each investigator has a profile showing what they cite most.
When was Criticare Technologies inspected by FDA?
The inspection ran Mar 21 – May 10, 2024, and the Form 483 is dated May 10, 2024.
How do I get the full Form 483 for Criticare Technologies?
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.