FDA inspection

Medelle Corporation: FDA inspection ending May 12, 2006

FDA inspection 425558 · Official Action Indicated (OAI) · Woburn, MA

Key facts

Inspection ID 425558
Firm Medelle Corporation
FEI number 3004549300
Address 500 W Cummings Park Ste 2750
City Woburn
State MA
ZIP 01801-6546
Fiscal year 2006
Inspection end date May 12, 2006
Classification Official Action Indicated (OAI)
Project area Product Evaluation: Med 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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