Company
JapanAOMI PRECISION CO LTD, Niigata, Japan – FDA Inspections
Inspection records and compliance data for AOMI PRECISION CO LTD in Niigata. 1 FDA inspection on record (1 OAI), 1 Form 483, last inspected July 24, 2025.
Company Profile
This profile covers AOMI PRECISION CO LTD based in Niigata, Japan.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 1
- VAI
- 0
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
Inspected July 24, 2025.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures1 inspection
- Lack of or inadequate procedures1 inspection
- Lack of or inadequate procedures - Acceptance activities1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 24, 2025 | OAI | Medical Devices & Rad Health · Product Evaluation: Medical Devices | 1278397 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
AOMI PRECISION CO LTD
FEI Number
3015217553
Address
Minami 787, Shimomagaridori;, Niigata, Japan
Country
Japan
ID: 34d8d9a9-3ebc-4633-8da2-a52998d23df4