FDA Inspection 1215114 — Oral Arts Dental Laboratories, Inc.

Oral Arts Dental Laboratories, Inc. — FEI 3005730680

The FDA completed an inspection of Oral Arts Dental Laboratories, Inc. on August 4, 2023 in Huntsville, AL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 4, 2023
Fiscal Year
2023
Product Type
Devices
Project Area
Compliance: Devices
Location
Huntsville, AL (United States)

Citations

IDCFRDescription
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures
320421 CFR 820.40(b)Change records, content