1290296

Drake Precision Dental Laboratory — FEI 3002706372

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
November 5, 2025
Fiscal Year
2026
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Charlotte, NC (United States)

Citations

IDCFRDescription
315921 CFR 820.184DHR content
317121 CFR 820.198(b)Rationale documented for no investigation
317321 CFR 820.198(d)Evaluation, timeliness, identification
323521 CFR 820.72(a)Equipment control activity documentation
334521 CFR 820.200(a)Servicing - Lack of or inadequate procedures
343221 CFR 820.75(b)(2)Documentation of validated process performance
366521 CFR 820.20(b)(3)Management representative
369621 CFR 820.100(b)Documentation