FDA Inspection
MIRA, Inc.MIRA, Inc. – FDA Inspection, Nov 5, 2009
Record Details
This FDA Inspection record concerns MIRA, Inc., with an inspection on November 5, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- MIRA, Inc.
- Inspection Date
- November 5, 2009
- Product Type
- Devices
View Company Profile
ID · 7b1ef131-0226-44a9-a288-8a3d105b2c27
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 626993
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.22Quality audits - auditor independence
- 21 CFR 820.200(b)Analyzing service report
- 21 CFR 820.200(a)Servicing - Lack of or inadequate procedures
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Other FDA inspections of MIRA, Inc.
10| 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 |
Other documents for MIRA, Inc.
- FDA Inspection 1276813 - 2025-07-23
- FDA Inspection 1241130 - 2024-06-12
- FDA Inspection 1199256 - 2023-03-07
- FDA Inspection 1156962 - 2021-11-18
- FDA Inspection 1041571 - 2018-02-20
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