FDA Inspection
Biolife, LLCBiolife, LLC – FDA Inspection, Aug 27, 2010
Record Details
This FDA Inspection record concerns Biolife, LLC, with an inspection on August 27, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Biolife, LLC
- Inspection Date
- August 27, 2010
- Product Type
- Devices
View Company Profile
ID · 6f99047c-cbd9-47c8-adfb-5f750b923836
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 677473
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.22Quality audits - auditor independence
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.60Identification procedures, Lack of or inadequate procedures
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Other FDA inspections of Biolife, LLC
5| Date | Classification | Office | Project area |
|---|---|---|---|
| May 15, 2019 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 14, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 28, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 26, 2012 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 31, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Biolife, LLC
- FDA Inspection 1097262 - 2019-05-15
- FDA Inspection 1015370 - 2017-06-14
- FDA Inspection 838415 - 2013-06-28
- FDA Inspection 764655 - 2012-01-26
- FDA Inspection 599890 - 2009-07-31
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