FDA Inspection 924037 — Coastal Contacts Inc.

Coastal Contacts Inc. — FEI 3006066935

The FDA completed an inspection of Coastal Contacts Inc. on Apr 9, 2015 in Vancouver. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 4 citations were issued during this inspection. Product area: Devices.

Inspection details

Classification
Voluntary Action Indicated (VAI)
End Date
Apr 9, 2015
Fiscal Year
2015
Product Type
Devices
Project Area
Compliance: 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

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