FDA Inspection
SUZUKEN CO., LTD. OGUCHI CENTERSUZUKEN CO., LTD. OGUCHI CENTER – FDA Inspection, Jun 27, 2018
Record Details
This FDA Inspection record concerns SUZUKEN CO., LTD. OGUCHI CENTER, with an inspection on June 27, 2018, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Inspection Date
- June 27, 2018
- Product Type
- Medical Devices & Rad Health
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ID · e3bedd18-8104-428e-b6f7-e5e4991c0d61
Inspection Facts
- Inspection number
- 1058815
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.40Procedures not adequately established or maintained
Full citation text and observation details available on the Dashboard.
Other FDA inspections of SUZUKEN CO., LTD. OGUCHI CENTER
3| Date | Classification | Office | Project area |
|---|---|---|---|
| June 17, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 30, 2014 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 15, 2010 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for SUZUKEN CO., LTD. OGUCHI CENTER
- FDA Inspection 933588 - 2015-06-17
- FDA Inspection 866643 - 2014-01-30
- FDA Inspection 708074 - 2010-12-15
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