FDA Inspection
Eurogreen International Inc.Eurogreen International Inc. – FDA Inspection, Mar 21, 2017
Record Details
This FDA Inspection record concerns Eurogreen International Inc., with an inspection on March 21, 2017, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Company
- Eurogreen International Inc.
- Inspection Date
- March 21, 2017
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · eb884cd7-aaad-4083-925a-9a004c0779f4
Inspection Facts
- Inspection number
- 1008807
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 820.100(b)Documentation
- 21 CFR 820.184DHR content
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.30(c)Design input - documentation
- 21 CFR 820.30(e)Design review - documentation
- 21 CFR 820.30(f)Design verification - documentation
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