FDA Inspection
Applied Neuro TechnologyApplied Neuro Technology – FDA Inspection, May 25, 2010
Record Details
This FDA Inspection record concerns Applied Neuro Technology, with an inspection on May 25, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Applied Neuro Technology
- Inspection Date
- May 25, 2010
- Product Type
- Devices
View Company Profile
ID · c37e3bad-0048-4996-8831-7708f07218af
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 662248
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
9- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 820.198(a)General
- 21 CFR 820.198(a)(3)Processing MDRs {see also 803, 804}
- 21 CFR 820.20(a)Management ensuring quality policy is understood
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.50(b)Approval, inadequate purchasing data
- 21 CFR 820.100(b)Procedures
- 21 CFR 820.50(a)(2)Supplier oversight
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