FDA inspection

Laboratorio Magnachem International, S.A.: FDA inspection ending Nov 10, 2023

FDA inspection 1224442 · Official Action Indicated (OAI) · Haina

Key facts

Inspection ID 1224442
Firm Laboratorio Magnachem International, S.A.
FEI number 3003320065
Address Esq Calle K, Ave Jose Francisco Pena Gomez
City Haina
Country Dominican Republic (the)
Fiscal year 2024
Inspection end date Nov 10, 2023
Classification Official Action Indicated (OAI)
Project area Drug Quality Assurance
Product type Drugs
Warning letter 673796

At a glance

  • None 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

Browse all FDA inspections