Criticare Technologies, Inc. – FDA Inspection, Mar 29, 2017

Record Details

This FDA Inspection record concerns Criticare Technologies, Inc., with an inspection on March 29, 2017, issued by the Center for Devices and Radiological Health, covering devices.

Company: Criticare Technologies, Inc.
Inspection Date: March 29, 2017
Product Type: Devices
Office: Center for Devices and Radiological Health
Person: Maryam Tabatabaie (Company Rep)

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ID · b97215a7-4821-4996-bf66-b9b0c62eb412

Inspection Facts

Official Action Indicated (OAI)

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

Inspection number: 1006521
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices
Outcome: Form 483 issued

FDA Citations

21 CFR 803.50(a)(2)Individual Report of Malfunction
21 CFR 820.40Procedures not adequately established or maintained
21 CFR 820.25(b)Training records
21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
21 CFR 820.100(a)Lack of or inadequate procedures
21 CFR 820.60Identification procedures, Lack of or inadequate procedures
21 CFR 820.198(a)Lack of or inadequate complaint procedures
21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
21 CFR 820.120Lack of or inadequate procedures for labeling
21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ

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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
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