FDA inspection

Sterling Diagnostics, Inc.: FDA inspection ending Dec 20, 2017

FDA inspection 1035513 · Voluntary Action Indicated (VAI) · Sterling Heights, MI

Key facts

Inspection ID 1035513
Firm Sterling Diagnostics, Inc.
FEI number 1831796
Address 36645 Metro Ct
City Sterling Heights
State MI
ZIP 48312
Country United States
Fiscal year 2018
Inspection end date Dec 20, 2017
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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