FDA Inspection
Human Biosciences, Inc.Human Biosciences, Inc. – FDA Inspection, Oct 18, 2011
Record Details
This FDA Inspection record concerns Human Biosciences, Inc., with an inspection on October 18, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Human Biosciences, Inc.
- Inspection Date
- October 18, 2011
- Product Type
- Devices
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ID · c5d72a7c-8207-46b4-8566-510fd04bc182
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 748491
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.70(g)Equipment design and installation
- 21 CFR 820.25(a)Personnel
- 21 CFR 820.70(c)Environmental control 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 |
| June 27, 2017 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: 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 |
Other documents for Human Biosciences, Inc.
- FDA Inspection 1162318 - 2022-02-15
- FDA Inspection 1017351 - 2017-06-27
- FDA Inspection 839569 - 2013-07-19
- FDA Inspection 810166 - 2013-01-04
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