FDA Inspection
Human Biosciences, Inc.Human Biosciences, Inc. – FDA Inspection, Jun 27, 2017
Record Details
This FDA Inspection record concerns Human Biosciences, Inc., with an inspection on June 27, 2017, issued by the Center for Devices and Radiological Health, covering devices.
- Person
- Erin L. Mcfiren (Issuing Officer)
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ID · 3fadaee9-1c66-425e-8b37-f2b97568da74
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1017351
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - 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 Human Biosciences, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| February 15, 2022 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 19, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 4, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 18, 2011 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Human Biosciences, Inc.
- FDA Inspection 1162318 - 2022-02-15
- FDA Inspection 839569 - 2013-07-19
- FDA Inspection 810166 - 2013-01-04
- FDA Inspection 748491 - 2011-10-18
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