FDA inspection

Medelle Corporation: FDA inspection ending Jul 1, 2004

FDA inspection 337612 · Official Action Indicated (OAI) · Woburn, MA

Key facts

Inspection ID 337612
Firm Medelle Corporation
FEI number 3004549300
Address 500 W Cummings Park Ste 2750
City Woburn
State MA
ZIP 01801-6546
Fiscal year 2004
Inspection end date Jul 1, 2004
Classification Official Action Indicated (OAI)
Project area Product Evaluation: Med Devices
Product type Devices

At a glance

  • None 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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