FDA Inspection
Osachi Co LtdOsachi Co Ltd – FDA Inspection, Aug 9, 2012
Record Details
This FDA Inspection record concerns Osachi Co Ltd, with an inspection on August 9, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Osachi Co Ltd
- Inspection Date
- August 9, 2012
- Product Type
- Devices
View Company Profile
ID · d48f9505-41f9-4f80-961f-286d6b2657d1
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 796660
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.80(e)Documentation
- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.200(a)Servicing - Lack of or inadequate procedures
- 21 CFR 820.30(f)Design verification - documentation
- 21 CFR 820.50(b)Supplier notification of changes
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Osachi Co Ltd
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 17, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Osachi Co Ltd
- FDA Inspection 942209 - 2015-09-17
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