FDA inspection

Sicor de Mexico S.A. de C.V.: FDA inspection ending Dec 13, 2019

FDA inspection 1115638 · Official Action Indicated (OAI) · Lerma De Villada

Key facts

Inspection ID 1115638
Firm Sicor de Mexico S.A. de C.V.
FEI number 3002808102
Address Avenida San Rafael 35, Lerma
City Lerma De Villada
Country Mexico
Fiscal year 2020
Inspection end date Dec 13, 2019
Classification Official Action Indicated (OAI)
Project area Drug Quality Assurance
Product type Drugs

At a glance

  • None Citations
  • 1–9 Posted citations
  • No Warning letter followed
  • Yes Form FDA 483 issued
  • Yes Establishment inspection report (EIR) exists
  • 10–99 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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