FDA Inspection 1110242 — CND Global Technologies Inc.

CND Global Technologies Inc. — FEI 3014576803

The FDA completed an inspection of CND Global Technologies Inc. on Nov 15, 2019 in Cumberland, RI. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 10 citations were issued during this inspection. Product area: Devices.

Inspection details

Classification
No Action Indicated (NAI)
End Date
Nov 15, 2019
Fiscal Year
2020
Product Type
Devices
Project Area
Radiation Control and Health Safety Act
Location
Cumberland, RI (United States)

Citations

IDCFRDescription
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures
237121 CFR 820.30(a)Design control - no procedures
310321 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
312021 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
313021 CFR 820.100(a)Lack of or inadequate procedures
313221 CFR 820.120Lack of or inadequate procedures for labeling
316021 CFR 820.184Lack of or inadequate DHR procedures
328221 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
47921 CFR 820.50Purchasing controls, Lack of or inadequate procedures
63021 CFR 803.17Lack of Written MDR Procedures

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.