Company
United StatesBiolife, LLC, Sarasota, FL – FDA Inspections
Inspection records and compliance data for Biolife, LLC in Sarasota, Florida. 6 FDA inspections on record (2 OAI), 1 Form 483, last inspected May 15, 2019.
Company Profile
This profile covers Biolife, LLC based in Sarasota, Florida, United States.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 2
- VAI
- 3
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected July 31, 2009. Last inspected May 15, 2019.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures2 inspections
- Complaints1 inspection
- Identification procedures, Lack of or inadequate procedures1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 15, 2019 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1097262 |
| June 14, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1015370 |
| June 28, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 838415 |
| January 26, 2012 | OAI | Medical Devices & Rad Health · Compliance: Devices | 764655 |
| August 27, 2010 | OAI | Medical Devices & Rad Health · Compliance: Devices | 677473 |
| July 31, 2009 | VAI | Medical Devices & Rad Health · Compliance: Devices | 599890 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Biolife, LLC
FEI Number
3003395204
Address
8163 25th Ct E, Sarasota, Florida 34243, United States
Country
United States
ID: ff5d8406-ab0e-4f14-9099-0c4c11848659