FDA Inspection
Nissha Medical Technologies (Ohio), Inc.Nissha Medical Technologies (Ohio), Inc. – FDA Inspection, Dec 15, 2017
Record Details
This FDA Inspection record concerns Nissha Medical Technologies (Ohio), Inc., with an inspection on December 15, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · de2b02cb-3581-41df-bc6b-1966577a034e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1036533
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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Other FDA inspections of Nissha Medical Technologies (Ohio), Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| October 28, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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