FDA Inspection 1321618 — Burbank Dental Lab Inc

Burbank Dental Lab Inc — FEI 3007233968

The FDA completed an inspection of Burbank Dental Lab Inc on June 11, 2026 in Burbank, CA. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 3 citations were issued during this inspection. Product area: Devices.

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
June 11, 2026
Fiscal Year
2026
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Burbank, CA (United States)

Citations

IDCFRDescription
23088ISO 13485:2016 Clause 7.1Records of risk management activities in product realization not maintained
23174ISO 13485:2016 Clause 7.5.6Records of validation of processes and necessary actions not maintained
23239ISO 13485:2016 Clause 8.3.1Records of nonconforming product and actions taken not maintained