FDA Inspection 924037 — Coastal Contacts Inc.

Coastal Contacts Inc. — FEI 3006066935

The FDA completed an inspection of Coastal Contacts Inc. on April 9, 2015 in Vancouver. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 4 citations were issued during this inspection. Product area: Devices.

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
April 9, 2015
Fiscal Year
2015
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Vancouver (Canada)

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
47921 CFR 820.50Purchasing controls, Lack of or inadequate procedures