FDA Inspection 1049647 — Anodyne Surgical

Anodyne Surgical — FEI 1929756

The FDA completed an inspection of Anodyne Surgical on April 25, 2018 in Saint Charles, MO. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 2 citations were issued during this inspection. Product area: Devices.

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
April 25, 2018
Fiscal Year
2018
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Saint Charles, MO (United States)

Citations

IDCFRDescription
316821 CFR 820.198(a)Complaints
328621 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate