1106559

Caliber Imaging and Diagnostics, Inc. — FEI 3001451602

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
October 10, 2019
Fiscal Year
2020
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Rochester, NY (United States)

Citations

IDCFRDescription
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures
1472221 CFR 820.40Procedures not adequately established or maintained
313021 CFR 820.100(a)Lack of or inadequate procedures
328221 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
47921 CFR 820.50Purchasing controls, Lack of or inadequate procedures
581321 CFR 1002.30(a)(2)Methods, devices, procedures for testing