FDA Inspection
Mani, Inc. - Kiyohara FacilityMani, Inc. - Kiyohara Facility – FDA Inspection, May 23, 2013
Record Details
This FDA Inspection record concerns Mani, Inc. - Kiyohara Facility, with an inspection on May 23, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- May 23, 2013
- Product Type
- Devices
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ID · 9ea1d801-84a1-4d3d-b8bd-672b70dbd749
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 837793
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.198(a)Complaints
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.30(c)Design input - Lack of or inadequate procedures
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Other FDA inspections of Mani, Inc. - Kiyohara Facility
2| Date | Classification | Office | Project area |
|---|---|---|---|
| July 11, 2018 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| October 7, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Mani, Inc. - Kiyohara Facility
- FDA Inspection 1060864 - 2018-07-11
- FDA Inspection 695735 - 2010-10-07
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