Company
United StatesBiomat USA Inc, Clearwater, FL – FDA Inspections
Inspection records and compliance data for Biomat USA Inc in Clearwater, Florida. 6 FDA inspections on record, last inspected October 30, 2017.
Company Profile
This profile covers Biomat USA Inc based in Clearwater, Florida, United States.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 0
- VAI
- 3
- NAI
- 3
- Form 483s
- 0
- Warning letters
- 0
First inspected March 6, 2009. Last inspected October 30, 2017.
Most cited issue areas
- Establish, maintain and follow manufacturing SOPs2 inspections
- Explanation of hazards1 inspection
- Labeling procedures to avoid labeling mix-ups1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| October 30, 2017 | NAI | Biologics · Blood and Blood Products | 1034809 |
| October 9, 2015 | NAI | Biologics · Blood and Blood Products | 945282 |
| December 13, 2013 | VAI | Biologics · Blood and Blood Products | 858689 |
| June 22, 2012 | NAI | Biologics · Blood and Blood Products | 787786 |
| December 28, 2010 | VAI | Biologics · Blood and Blood Products | 703347 |
| March 6, 2009 | VAI | Biologics · Blood and Blood Products | 567091 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Biomat USA Inc
FEI Number
3000215056
Address
17900 Us Highway 19 N, Clearwater, Florida 33764, United States
Country
United States
ID: 208f2de8-5443-4f2c-87fd-5b0f477fb169