FDA Inspection 1019833 — Boston Scientific Corporation

Boston Scientific Corporation — FEI 3002095335

The FDA completed an inspection of Boston Scientific Corporation on Apr 27, 2017 in Maple Grove, MN. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 2 citations were issued during this inspection. Product area: Devices.

Inspection details

Classification
No Action Indicated (NAI)
End Date
Apr 27, 2017
Fiscal Year
2017
Product Type
Devices
Project Area
Compliance: Devices
Location
Maple Grove, MN (United States)

Citations

IDCFRDescription
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures
313021 CFR 820.100(a)Lack of or inadequate procedures

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