FDA Inspection
Mainstay Medical Limited US, Inc.Mainstay Medical Limited US, Inc. – FDA Inspection, Dec 20, 2019
Record Details
This FDA Inspection record concerns Mainstay Medical Limited US, Inc., with an inspection on December 20, 2019, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- December 20, 2019
- Product Type
- Devices
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ID · e605faed-1bdf-49f3-837f-6efa4dba04d6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1113373
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
2- 21 CFR 812.40Sponsors" general responsibilities
- 21 CFR 812.150(b)(5)Sponsor progress reports for significant risk study
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Other FDA inspections of Mainstay Medical Limited US, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 30, 2023 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Mainstay Medical Limited US, Inc.
- FDA Inspection 1216990 - 2023-06-30
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