FDA inspection

Syntex Puerto Rico, Inc.: FDA inspection ending Dec 6, 2000

FDA inspection 54879 · Voluntary Action Indicated (VAI) · Humacao, PR

Key facts

Inspection ID 54879
Firm Syntex Puerto Rico, Inc.
FEI number 3001586049
Address Bo Mariana Rd 909 Km 1.1
City Humacao
State PR
ZIP 00791
Fiscal year 2001
Inspection end date Dec 6, 2000
Classification Voluntary Action Indicated (VAI)
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
  • No 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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