FDA inspection

Laboratorios Sophia, S.A. De C.V.: FDA inspection ending Dec 14, 2018

FDA inspection 1075932 · Voluntary Action Indicated (VAI) · Zapopan

Key facts

Inspection ID 1075932
Firm Laboratorios Sophia, S.A. De C.V.
FEI number 1000310459
Address Av. Paseo Del Norte No. 5255, Guadalajara Technology Park
City Zapopan
Country Mexico
Fiscal year 2019
Inspection end date Dec 14, 2018
Classification Voluntary Action Indicated (VAI)
Project area Drug Quality Assurance
Product type Drugs

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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