Criticare Technologies, Inc. – FDA Inspection, May 10, 2024

Record Details

This FDA Inspection record concerns Criticare Technologies, Inc., with an inspection on May 10, 2024, issued by the Center for Devices and Radiological Health, covering devices.

Company: Criticare Technologies, Inc.
Inspection Date: May 10, 2024
Product Type: Devices
Office: Center for Devices and Radiological Health
Person: Sara M. Onyango (Issuing Officer)

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ID · 88f65312-9e93-414e-bbda-e2999733fec4

Inspection Facts

Official Action Indicated (OAI)

Significant objectionable conditions were found and regulatory or administrative action is recommended.

Inspection number: 1238217
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices
Enforcement: Warning Letter

FDA Citations

21 CFR 820.100(a)Lack of or inadequate procedures
21 CFR 820.198(a)Lack of or inadequate complaint procedures
21 CFR 820.25(b)Training records
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 not performed/inadequate
21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
21 CFR 830.300(a)Devices subject to device identification GUDID data submission requirements.

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Other FDA inspections of Criticare Technologies, Inc.

Date	Classification	Office	Project area
October 28, 2025	OAI		Compliance: Medical 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