FDA Inspection
Criticare Technologies, Inc.Criticare Technologies, Inc. – FDA Inspection, Oct 28, 2025
Record Details
This FDA Inspection record concerns Criticare Technologies, Inc., with an inspection on October 28, 2025, covering medical devices & rad health.
- Company
- Criticare Technologies, Inc.
- Inspection Date
- October 28, 2025
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · c650201a-3568-4714-ac8e-6e32f2ae2568
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1289170
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
FDA Citations
8- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.30(f)Design verification - output does not meet input requirement
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation - Risk analysis
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.70(a)Production processes
- 21 CFR 820.72(b)Remedial action
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Criticare Technologies, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| May 10, 2024 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 29, 2019 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| June 11, 2018 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 29, 2017 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
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