FDA inspection

Sterling Diagnostics, Inc.: FDA inspection ending Jul 28, 2016

FDA inspection 980678 · Official Action Indicated (OAI) · Sterling Heights, MI

Key facts

Inspection ID 980678
Firm Sterling Diagnostics, Inc.
FEI number 1831796
Address 36645 Metro Ct
City Sterling Heights
State MI
ZIP 48312
Country United States
Fiscal year 2016
Inspection end date Jul 28, 2016
Classification Official Action Indicated (OAI)
Project area Postmarket Assurance: Devices
Product type Devices

At a glance

  • 10–99 Citations
  • 1–9 Posted citations
  • No Warning letter followed
  • Yes Form FDA 483 issued
  • Yes 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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