Company
United StatesCriticare Technologies, Inc., Warwick, RI – FDA Inspections
Inspection records and compliance data for Criticare Technologies, Inc. in Warwick, Rhode Island. 5 FDA inspections on record (4 OAI), 3 Form 483s, 1 warning letter, last inspected October 28, 2025.
Company Profile
This profile covers Criticare Technologies, Inc. based in Warwick, Rhode Island, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 4
- VAI
- 1
- NAI
- 0
- Form 483s
- 3
- Warning letters
- 1
First inspected March 29, 2017. Last inspected October 28, 2025.
Most cited issue areas
- Lack of or inadequate procedures5 inspections
- Purchasing controls, Lack of or inadequate procedures4 inspections
- Lack of or inadequate complaint procedures3 inspections
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| October 28, 2025 | OAI | Medical Devices & Rad Health · Compliance: Medical Devices | 1289170 |
| May 10, 2024 | OAI | Medical Devices & Rad Health · Compliance: Devices | 1238217 |
| October 29, 2019 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1107892 |
| June 11, 2018 | OAI | Medical Devices & Rad Health · Compliance: Devices | 1055131 |
| March 29, 2017 | OAI | Medical Devices & Rad Health · Compliance: Devices | 1006521 |
FDA documents
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Company Information
Name
Criticare Technologies, Inc.
FEI Number
3012238587
Address
333 Strawberry Field Rd Ste 11, Warwick, Rhode Island 02886, United States
Country
United States
ID: f0597e63-c149-46f6-a474-fe9c1c8a951a