FDA Inspection
Access Bio, Inc.Access Bio, Inc. – FDA Inspection, Aug 31, 2010
Record Details
This FDA Inspection record concerns Access Bio, Inc., with an inspection on August 31, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Access Bio, Inc.
- Inspection Date
- August 31, 2010
- Product Type
- Devices
View Company Profile
ID · 9b529458-a8b0-446b-b28b-091ab576d0cf
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 675952
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.40(a)Document review, approval by designated individual
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 820.184DHR content
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Access Bio, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| September 27, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 29, 2011 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 25, 2010 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Access Bio, Inc.
- FDA Inspection 993227 - 2016-09-27
- FDA Inspection 734128 - 2011-08-29
- FDA Inspection 664896 - 2010-05-25
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