FDA Inspection
Andromeda LlcAndromeda Llc – FDA Inspection, Nov 15, 2012
Record Details
This FDA Inspection record concerns Andromeda Llc, with an inspection on November 15, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Andromeda Llc
- Inspection Date
- November 15, 2012
- Product Type
- Devices
View Company Profile
ID · 6c1bd0b1-95e3-4565-b99a-e5bf38f9da5f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 807871
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
5- 21 CFR 820.30(f)Design verification - output does not meet input requirement
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.200(a)Servicing - Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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