MIRA, Inc. – FDA Inspection, Jul 21, 2010

Record Details

This FDA Inspection record concerns MIRA, Inc., with an inspection on July 21, 2010, issued by the Center for Devices and Radiological Health, covering devices.

Company: MIRA, Inc.
Inspection Date: July 21, 2010
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · d0cc45d3-225c-4cc7-847c-d56a2bc1f2ea

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 674769
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices

FDA Citations

21 CFR 803.50(a)(2)Individual Report of Malfunction
21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
21 CFR 806.10(b)Time to report - 10 days
21 CFR 820.198(c)Investigation of device failures
21 CFR 820.100(a)(4)CAPA verification/validation of corrective/preventive action
21 CFR 820.40Lack of procedures, or not maintained
21 CFR 820.25(b)Training records
21 CFR 820.80(b)Incoming inspection, testing, verification
21 CFR 820.70(c)Environmental control system-documentation/review inspection
21 CFR 820.170(a)Lack of or inadequate instructions

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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