FDA Inspection
Criticare Technologies, Inc.Criticare Technologies, Inc. – FDA Inspection, Jun 11, 2018
Record Details
This FDA Inspection record concerns Criticare Technologies, Inc., with an inspection on June 11, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · bdcca0bc-082e-4f3a-982a-0e6c2eac2260
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1055131
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.200(a)Servicing - Lack of or inadequate procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
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Other FDA inspections of Criticare Technologies, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| October 28, 2025 | OAI | Compliance: Medical Devices | |
| 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 |
| March 29, 2017 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
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