FDA Inspection 1066052 — Alan Neuromedical Technologies

Alan Neuromedical Technologies — FEI 3010141624

The FDA completed an inspection of Alan Neuromedical Technologies on September 13, 2018 in The Woodlands, TX. 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
September 13, 2018
Fiscal Year
2018
Product Type
Devices
Project Area
Compliance: Devices
Location
The Woodlands, TX (United States)

Citations

IDCFRDescription
316821 CFR 820.198(a)Complaints
341521 CFR 820.22Quality Audit/Reaudit - conducted
342521 CFR 820.50(a)(1)Evaluation and Selection, Suppliers, Contractors, etc.