FDA inspection

GEM City Enginnering and Manufacturing Corporation: FDA inspection ending Mar 1, 2018

FDA inspection 1042745 · Voluntary Action Indicated (VAI) · Dayton, OH

Key facts

Inspection ID 1042745
Firm GEM City Enginnering and Manufacturing Corporation
FEI number 3009885329
Address 401 Leo St
City Dayton
State OH
ZIP 45404
Country United States
Fiscal year 2018
Inspection end date Mar 1, 2018
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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