FDA Inspection
McGan Technology LLCMcGan Technology LLC – FDA Inspection, Feb 5, 2013
Record Details
This FDA Inspection record concerns McGan Technology LLC, with an inspection on February 5, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- McGan Technology LLC
- Inspection Date
- February 5, 2013
- Product Type
- Devices
View Company Profile
ID · 3a8707dd-b903-4458-97f7-968ffd15c740
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 817124
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.50(b)Supplier notification of changes
- 21 CFR 803.17Lack of Written MDR Procedures
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