Orca1

FDA inspection

Respironics California, LLC: FDA inspection ending May 8, 2014

FDA inspection 879330 · Administrative/Directed Change (ADC) · Carlsbad, CA

Key facts

Inspection ID 879330
Firm Respironics California, LLC
FEI number 3002470603
Address 2271 Cosmos Ct
City Carlsbad
State CA
ZIP 92011-1517
Fiscal year 2014
Inspection end date May 8, 2014
Classification Administrative/Directed Change (ADC)
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Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket 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Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices
Product type Devices
Warning letter 432772

At a glance

  • None Citations
  • 1–9 Posted citations
  • Yes 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.

Other inspections at this establishment

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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