FDA inspection

Ortho Biologics, LLC: FDA inspection ending Jun 28, 2010

FDA inspection 669409 · Voluntary Action Indicated (VAI) · Manati, PR

Key facts

Inspection ID 669409
Firm Ortho Biologics, LLC
FEI number 1000110299
Address Rd 2 Km 45.6 Bo Campo Alegre
City Manati
State PR
ZIP 00674
Country United States
Fiscal year 2010
Inspection end date Jun 28, 2010
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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