MIRA, Inc. – FDA Inspection, Nov 9, 2016

Record Details

This FDA Inspection record concerns MIRA, Inc., with an inspection on November 9, 2016, issued by the Center for Devices and Radiological Health, covering devices.

Company: MIRA, Inc.
Inspection Date: November 9, 2016
Product Type: Devices
Office: Center for Devices and Radiological Health
Person: Jeffrey J. Thibodeau (FDA Associated Person)

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ID · a2daed2e-488c-41bc-890f-44222966ae4f

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 992407
FDA center: Medical Devices & Rad Health
Project area: Postmarket Assurance: Devices
Outcome: Form 483 issued

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 820.30(f)Design verification - output does not meet input requirement
21 CFR 820.22Quality audits - auditor independence
21 CFR 820.100(a)Lack of or inadequate procedures
21 CFR 820.250(a)Statistical techniques - 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(g)Design Validation - Risk analysis not performed/inadequate
21 CFR 820.30(g)Design validation - simulated testing

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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