FDA Inspection
Diotech Co. Ltd.Diotech Co. Ltd. – FDA Inspection, Jul 28, 2017
Record Details
This FDA Inspection record concerns Diotech Co. Ltd., with an inspection on July 28, 2017, issued by the Center for Devices and Radiological Health, covering devices.
- Person
- Amy M. Cramer (Issuing Officer)
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ID · ab2d3efd-90e1-4619-a57c-720960047f5b
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1020606
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
11- 21 CFR 1010.2(b)Certification label or tag
- 21 CFR 1040.10(h)(1)(i)User information, adequate instructions
- 21 CFR 820.198(a)Complaints
- 21 CFR 820.25(b)Training records
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation - software validation documentation
- 21 CFR 820.20(b)Lack of or inadequate organizational structure
- 21 CFR 803.17Lack of Written MDR Procedures
- 21 CFR 1002.13Failure to submit
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