MIRA, Inc. – FDA Inspection, Jul 31, 2014

Record Details

This FDA Inspection record concerns MIRA, Inc., with an inspection on July 31, 2014, issued by the Center for Devices and Radiological Health, covering devices.

Company: MIRA, Inc.
Inspection Date: July 31, 2014
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · a86c3002-beee-4a86-82a9-e713bf050210

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 890215
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices

FDA Citations

21 CFR 803.50(a)(2)Individual Report of Malfunction
21 CFR 820.75(a)Lack of or inadequate process validation
21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
21 CFR 820.100(a)Lack of or inadequate procedures
21 CFR 820.20(c)Management review - Lack of or inadequate procedures
21 CFR 820.22Quality audits - Lack of or inadequate procedures
21 CFR 820.25(b)Training - Lack of or inadequate procedures
21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
21 CFR 820.30(j)Design history file

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Other FDA inspections of MIRA, Inc.

Date	Classification	Office	Project area
July 23, 2025	Not classified	New England District Office
June 12, 2024	Not classified	New England District Office	Compliance: Devices
March 7, 2023	NAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices
November 18, 2021	NAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices
February 20, 2018	VAI	Center for Devices and Radiological Health	Compliance: Devices