FDA Inspection
Afton Medical, LLCAfton Medical, LLC – FDA Inspection, Jul 11, 2014
Record Details
This FDA Inspection record concerns Afton Medical, LLC, with an inspection on July 11, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Afton Medical, LLC
- Inspection Date
- July 11, 2014
- Product Type
- Devices
View Company Profile
ID · a27030c2-c15b-4dcc-9039-c542da55b24b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 888129
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
9- 21 CFR 820.40(a)Document review, approval by designated individual
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.60Identification procedures, Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.30(j)Design history file
- 21 CFR 803.17Lack of Written MDR Procedures
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