Company
JapanBIONICM, Bunkyo, Japan – FDA Inspections
Inspection records and compliance data for BIONICM in Bunkyo. 1 FDA inspection on record, 1 Form 483, last inspected August 20, 2026.
Company Profile
This profile covers BIONICM based in Bunkyo, Japan.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 0
- NAI
- 0
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
Inspected August 20, 2026.
Most cited issue areas
- Lack of documented justification for not investigating complaint(s)1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 20, 2026 | Not classified | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1335880 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
BIONICM
FEI Number
3027645766
Address
The University Of Tokyo Entrepreneur Plaza 203, Hongo, Bunkyo, Japan
Country
Japan
ID: c105f820-1d92-4fe1-9430-45fc4a45c724