FDA inspection

Synthes (USA) Products LLC: FDA inspection ending Oct 20, 2017

FDA inspection 1029323 · Voluntary Action Indicated (VAI) · West Chester, PA

Key facts

Inspection ID 1029323
Firm Synthes (USA) Products LLC
FEI number 3008812560
Address 1303 Goshen Pkwy
City West Chester
State PA
ZIP 19380
Country United States
Fiscal year 2018
Inspection end date Oct 20, 2017
Classification Voluntary Action Indicated (VAI)
Project area Compliance: 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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