FDA inspection

Cotton High Tech S.L.( d/ba COHITECH): FDA inspection ending Aug 8, 2013

FDA inspection 852538 · Official Action Indicated (OAI) · Balsareny

Key facts

Inspection ID 852538
Firm Cotton High Tech S.L.( d/ba COHITECH)
FEI number 3006517653
Address Colonia La Rabeia S/N
City Balsareny
Country Spain
Fiscal year 2013
Inspection end date Aug 8, 2013
Classification Official Action Indicated (OAI)
Project area Postmarket Assurance: Devices
Product type Devices
Warning letter 415941

At a glance

  • 1–9 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.

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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