FDA Inspection
Seon Medical, LtdSeon Medical, Ltd – FDA Inspection, Jan 14, 2010
Record Details
This FDA Inspection record concerns Seon Medical, Ltd, with an inspection on January 14, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Seon Medical, Ltd
- Inspection Date
- January 14, 2010
- Product Type
- Devices
View Company Profile
ID · dab8083b-c45c-4606-917d-b25e852203d8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 644225
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
5- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.25(b)Training
- 21 CFR 820.70(g)Equipment design and installation
- 21 CFR 820.100(a)(3)Identification of actions needed
- 21 CFR 820.72(b)(2)Calibration documentation
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