Company
JapanA&D Company Manufacturing, Ltd., Shimotsuma, Japan – FDA Inspections
Inspection records and compliance data for A&D Company Manufacturing, Ltd. in Shimotsuma. 5 FDA inspections on record, 1 Form 483, last inspected March 17, 2023.
Company Profile
This profile covers A&D Company Manufacturing, Ltd. based in Shimotsuma, Japan.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 3
- NAI
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected February 19, 2009. Last inspected March 17, 2023.
Most cited issue areas
- DHR - not or inadequately maintained1 inspection
- Documentation1 inspection
- Investigation of device failures1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 17, 2023 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1200951 |
| June 21, 2018 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1061532 |
| July 22, 2016 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 988304 |
| June 6, 2014 | VAI | Medical Devices & Rad Health · Compliance: Devices | 885554 |
| February 19, 2009 | VAI | Medical Devices & Rad Health · Compliance: Devices | 574101 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
A&D Company Manufacturing, Ltd.
FEI Number
3006899423
Address
4210-15, Takasai, Shimotsuma, Japan
Country
Japan
ID: 54b0e753-4db6-4224-add8-f65f9b5afee5