FDA Inspection
InBios International, Inc.InBios International, Inc. – FDA Inspection, Aug 23, 2018
Record Details
This FDA Inspection record concerns InBios International, Inc., with an inspection on August 23, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 8386e279-fd78-4cf4-98cc-3d445136c215
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1064523
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.250(b)Sampling plans
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.72(b)Remedial action
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Other FDA inspections of InBios International, Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| June 16, 2022 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| May 15, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 22, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 4, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 27, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for InBios International, Inc.
- FDA Inspection 1172098 - 2022-06-16
- FDA Inspection 927383 - 2015-05-15
- FDA Inspection 827548 - 2013-04-22
- FDA Inspection 779697 - 2012-05-04
- FDA Inspection 683144 - 2010-08-27
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