FDA Inspection
Biolife, LLCBiolife, LLC – FDA Inspection, Jun 14, 2017
Record Details
This FDA Inspection record concerns Biolife, LLC, with an inspection on June 14, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · c3898726-c1dd-4061-9ca3-6a2a5dc26ab7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1015370
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.198(a)Complaints
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 803.17Lack of Written MDR 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 28, 2013 | 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 838415 - 2013-06-28
- FDA Inspection 764655 - 2012-01-26
- FDA Inspection 677473 - 2010-08-27
- FDA Inspection 599890 - 2009-07-31
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