FDA Inspection
Minaris Medical America, Inc.Minaris Medical America, Inc. – FDA Inspection, Aug 6, 2010
Record Details
This FDA Inspection record concerns Minaris Medical America, Inc., with an inspection on August 6, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- August 6, 2010
- Product Type
- Devices
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ID · b83a9580-bb5d-481f-ba3d-87a63219f04c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 675121
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
3- 21 CFR 806.10(a)(1)Report of risk to health
- 21 CFR 820.80(c)Lack of or inadequate In-process acceptance procedures
- 21 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
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Other FDA inspections of Minaris Medical America, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| December 16, 2022 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| June 6, 2019 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 21, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 11, 2012 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Minaris Medical America, Inc.
- FDA Inspection 1194876 - 2022-12-16
- FDA Inspection 1097911 - 2019-06-06
- FDA Inspection 923042 - 2015-04-21
- FDA Inspection 792552 - 2012-07-11
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