FDA inspection

Lotte Biologics USA, LLC: FDA inspection ending Dec 16, 2010

FDA inspection 704419 · No Action Indicated (NAI) · East Syracuse, NY

Key facts

Inspection ID 704419
Firm Lotte Biologics USA, LLC
FEI number 1317757
Address 6000 Thompson Rd
City East Syracuse
State NY
ZIP 13057-5051
Fiscal year 2011
Inspection end date Dec 16, 2010
Classification No Action Indicated (NAI)
Project area Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs|Bioresearch Monitoring: Human Drugs
Product type Drugs

At a glance

  • None Citations
  • None 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

Browse all FDA inspections