FDA Inspection
Minta Medical LimitedMinta Medical Limited – FDA Inspection, Jan 9, 2025
Record Details
This FDA Inspection record concerns Minta Medical Limited, with an inspection on January 9, 2025, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · 711123bf-5bc0-48bc-94fd-0e4a872154c5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1258667
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Minta Medical Limited
2| Date | Classification | Office | Project area |
|---|---|---|---|
| July 28, 2022 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 29, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Minta Medical Limited
- FDA Inspection 1176360 - 2022-07-28
- FDA Inspection 946148 - 2015-10-29
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