FDA Inspection 1201361 — Gergens Orthodontic Lab, Inc.

Gergens Orthodontic Lab, Inc. — FEI 3008274496

The FDA completed an inspection of Gergens Orthodontic Lab, Inc. on March 30, 2023 in Phoenix, AZ. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 1 citation was issued during this inspection. Product area: Devices.

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
March 30, 2023
Fiscal Year
2023
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Phoenix, AZ (United States)

Citations

IDCFRDescription
341521 CFR 820.22Quality Audit/Reaudit - conducted