FDA Inspection
Mani, Inc. - Kiyohara FacilityMani, Inc. - Kiyohara Facility – FDA Inspection, Oct 7, 2010
Record Details
This FDA Inspection record concerns Mani, Inc. - Kiyohara Facility, with an inspection on October 7, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- October 7, 2010
- Product Type
- Devices
View Company Profile
ID · 805ed79b-2d18-4bfd-a01c-71ac1b8a2832
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 695735
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.198(a)Complaints
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.25(b)Training records
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.250(b)Sampling plans
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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 |
| May 23, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Mani, Inc. - Kiyohara Facility
- FDA Inspection 1060864 - 2018-07-11
- FDA Inspection 837793 - 2013-05-23
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