FDA Inspection
Medyssey Co., Ltd.Medyssey Co., Ltd. – FDA Inspection, Jun 19, 2014
Record Details
This FDA Inspection record concerns Medyssey Co., Ltd., with an inspection on June 19, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Medyssey Co., Ltd.
- Inspection Date
- June 19, 2014
- Product Type
- Devices
View Company Profile
ID · ec91d4c9-4a02-4cef-91f5-e26cc818617a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 885466
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
7- 21 CFR 820.75(a)Lack of or inadequate process validation
- 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(f)Design verification - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
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