FDA inspection

Synchronis Medical Llc: FDA inspection ending Jun 4, 2024

FDA inspection 1240289 · Voluntary Action Indicated (VAI) · Romulus, MI

Key facts

Inspection ID 1240289
Firm Synchronis Medical Llc
FEI number 3014527916
Address 11501 Metro Airport Center Dr Ste 100
City Romulus
State MI
ZIP 48174
Country United States
Fiscal year 2024
Inspection end date Jun 4, 2024
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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