FDA Inspection 769059 — Neuro-Fitness LLC

Neuro-Fitness LLC — FEI 3005026995

The FDA completed an inspection of Neuro-Fitness LLC on February 22, 2012 in Fall City, WA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
February 22, 2012
Fiscal Year
2012
Product Type
Devices
Project Area
Compliance: Devices
Location
Fall City, WA (United States)

Citations

IDCFRDescription
232721 CFR 820.22Quality audits - Lack of or inadequate procedures
328221 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
47921 CFR 820.50Purchasing controls, Lack of or inadequate procedures