Company
United StatesBionica Inc., Mcclellan, CA – FDA Inspections
Inspection records and compliance data for Bionica Inc. in Mcclellan, California. 4 FDA inspections on record, 1 Form 483, last inspected July 16, 2018.
Company Profile
This profile covers Bionica Inc. based in Mcclellan, California, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 1
- NAI
- 3
- Form 483s
- 1
- Warning letters
- 0
First inspected December 3, 2009. Last inspected July 16, 2018.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures1 inspection
- Design validation - Risk analysis1 inspection
- Lack of or inadequate complaint procedures1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 16, 2018 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1061626 |
| June 9, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1013534 |
| October 14, 2014 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 901734 |
| December 3, 2009 | NAI | Medical Devices & Rad Health · Compliance: Devices | 633383 |
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
Bionica Inc.
FEI Number
3004435660
Address
5112 Bailey Loop, Mcclellan, California 95652, United States
Country
United States
ID: 8f9baba5-e23e-44c8-bce4-ffa0713be196