Company
United StatesBioseal, Placentia, CA – FDA Inspections
Inspection records and compliance data for Bioseal in Placentia, California. 3 FDA inspections on record, 1 Form 483, last inspected September 21, 2017.
Company Profile
This profile covers Bioseal based in Placentia, California, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 2
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected October 28, 2010. Last inspected September 21, 2017.
Most cited issue areas
- Lack of or inadequate final acceptance procedures1 inspection
- Records of MDR Investigation1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 21, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1026418 |
| December 5, 2012 | VAI | Medical Devices & Rad Health · Compliance: Devices | 810930 |
| October 28, 2010 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 696333 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Bioseal
FEI Number
2027062
Address
167 W Orangethorpe Ave, Placentia, California 92870, United States
Country
United States
ID: e392ffcc-a9b7-47a6-a035-860c3d99eb10