FDA inspection

Philips Medical Systems (Cleveland) Inc: FDA inspection ending Dec 3, 2010

FDA inspection 679230 · Official Action Indicated (OAI) · Cleveland, OH

Key facts

Inspection ID 679230
Firm Philips Medical Systems (Cleveland) Inc
FEI number 1525965
Address 595 Miner Rd
City Cleveland
State OH
ZIP 44143
Country United States
Fiscal year 2011
Inspection end date Dec 3, 2010
Classification Official Action Indicated (OAI)
Project area Compliance: Devices
Product type Devices
Warning letter 158993

At a glance

  • 10–99 Citations
  • 1–9 Posted citations
  • Yes Warning letter followed
  • Yes Form FDA 483 issued
  • No Establishment inspection report (EIR) exists
  • 10–99 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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