FDA Inspection
Inovar IncInovar Inc – FDA Inspection, Oct 21, 2016
Record Details
This FDA Inspection record concerns Inovar Inc, with an inspection on October 21, 2016, issued by the Center for Devices and Radiological Health, covering devices.
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ID · b8c01647-f772-45aa-986b-1dcbd330071a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 991154
- FDA center
- Medical Devices & Rad Health
- Project area
- Radiation Control and Health Safety Act
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 820.100(b)Documentation
- 21 CFR 1010.2(a)Lack of certification of conformance
- 21 CFR 820.198(b)Review and evaluation for investigation
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
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Other FDA inspections of Inovar Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| October 4, 2018 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Inovar Inc
- FDA Inspection 1068866 - 2018-10-04
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