Criticare Technologies, Inc. – FDA Inspection, Oct 29, 2019

Record Details

This FDA Inspection record concerns Criticare Technologies, Inc., with an inspection on October 29, 2019, issued by the Center for Devices and Radiological Health, covering devices.

Company: Criticare Technologies, Inc.
Inspection Date: October 29, 2019
Product Type: Devices
Office: Center for Devices and Radiological Health

View Company Profile

ID · b418b023-d0c9-4f67-aa8a-9b217dec5dbd

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number: 1107892
FDA center: Medical Devices & Rad Health
Project area: Postmarket Assurance: Devices

FDA Citations

21 CFR 820.198(c)Investigation of device failures
21 CFR 820.40Lack of procedures, or not maintained
21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
21 CFR 820.100(a)Lack of or inadequate procedures
21 CFR 820.30(a)Design control - no procedures
21 CFR 820.140Lack of or inadequate procedures for handling
21 CFR 820.250(b)Sampling methods - Lack of or inadequate procedures
21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
21 CFR 820.22Quality Audit/Reaudit - conducted
21 CFR 820.184DHR content

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Criticare Technologies, Inc.

Date	Classification	Office	Project area
October 28, 2025	OAI		Compliance: Medical Devices
May 10, 2024	OAI	Center for Devices and Radiological Health	Compliance: 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