FDA Inspection
Okamoto Industries Inc.Okamoto Industries Inc. – FDA Inspection, Oct 22, 2010
Record Details
This FDA Inspection record concerns Okamoto Industries Inc., with an inspection on October 22, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Okamoto Industries Inc.
- Inspection Date
- October 22, 2010
- Product Type
- Devices
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ID · a1271b8e-451e-486f-8159-608eeba7ed8d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 695676
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
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