FDA inspection

Synthes (USA) Products LLC: FDA inspection ending Oct 29, 2010

FDA inspection 695834 · Voluntary Action Indicated (VAI) · West Chester, PA

Key facts

Inspection ID 695834
Firm Synthes (USA) Products LLC
FEI number 3008812560
Address 1303 Goshen Pkwy
City West Chester
State PA
ZIP 19380
Country United States
Fiscal year 2011
Inspection end date Oct 29, 2010
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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