FDA inspection

Patheon Puerto Rico, Inc.: FDA inspection ending Jun 21, 2016

FDA inspection 976890 · Voluntary Action Indicated (VAI) · Manati, PR

Key facts

Inspection ID 976890
Firm Patheon Puerto Rico, Inc.
FEI number 3003113148
Address State Rd. 670, Km. 2.7
City Manati
State PR
ZIP 00674
Country United States
Fiscal year 2016
Inspection end date Jun 21, 2016
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
  • 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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