FDA inspection

Bolton Medical Inc.: FDA inspection ending Sep 12, 2016

FDA inspection 987958 · Voluntary Action Indicated (VAI) · Sunrise, FL

Key facts

Inspection ID 987958
Firm Bolton Medical Inc.
FEI number 1000135961
Address 799 International Pkwy
City Sunrise
State FL
ZIP 33325
Country United States
Fiscal year 2016
Inspection end date Sep 12, 2016
Classification Voluntary Action Indicated (VAI)
Project area Postmarket Assurance: Devices
Product type Devices

At a glance

  • 1–9 Citations
  • 1–9 Posted citations
  • No Warning letter followed
  • Yes Form FDA 483 issued
  • No Establishment inspection report (EIR) exists
  • 1–9 Inspections at this FEI

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA inspections

FDA inspections are classified as No Action Indicated (NAI), Voluntary Action Indicated (VAI) or Official Action Indicated (OAI). Inspections of individual clinical investigators are not published here.

Source: U.S. Food and Drug Administration (FDA), inspection classification data

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