1290306

Turbett Surgical, Inc. — FEI 3012421755

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
November 6, 2025
Fiscal Year
2026
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Henrietta, NY (United States)

Citations

IDCFRDescription
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures
326221 CFR 820.250(a)Statistical techniques - Lack of or inadequate procedures
328521 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
369621 CFR 820.100(b)Documentation