FDA Inspection 993872 — Suture Concepts

Suture Concepts — FEI 3012101526

The FDA completed an inspection of Suture Concepts on Dec 8, 2016 in Beverly, MA. 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). 1 citation was issued during this inspection. Product area: Devices.

Inspection Details

Classification
Voluntary Action Indicated (VAI)
End Date
Dec 8, 2016
Fiscal Year
2017
Product Type
Devices
Project Area
Compliance: Devices
Location
Beverly, MA (United States)

Citations

IDCFRDescription
50221 CFR 820.60Identification procedures, Lack of or inadequate procedures

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