FDA Inspection
Biolife, LLCBiolife, LLC – FDA Inspection, Jun 28, 2013
Record Details
This FDA Inspection record concerns Biolife, LLC, with an inspection on June 28, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Biolife, LLC
- Inspection Date
- June 28, 2013
- Product Type
- Devices
View Company Profile
ID · e9b0c363-befd-4ab6-a516-de6596e10ae9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 838415
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 803.17(a)(2)Lack of System for Determining MDR Events
Full citation text and observation details available on the Dashboard.
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 |
| January 26, 2012 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 27, 2010 | 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 764655 - 2012-01-26
- FDA Inspection 677473 - 2010-08-27
- FDA Inspection 599890 - 2009-07-31
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