FDA inspection

Lumenis, Inc.: FDA inspection ending Feb 27, 2004

FDA inspection 315983 · Official Action Indicated (OAI) · Salt Lake City, UT

Key facts

Inspection ID 315983
Firm Lumenis, Inc.
FEI number 1720381
Address 1870 S Milestone Dr
City Salt Lake City
State UT
ZIP 84104-6541
Fiscal year 2004
Inspection end date Feb 27, 2004
Classification Official Action Indicated (OAI)
Project area Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med 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Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth
Product type Devices

At a glance

  • 10–99 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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