FDA inspection

LOTTE Biologics USA, LLC: FDA inspection ending Sep 19, 2024

FDA inspection 1246771 · No Action Indicated (NAI) · East Syracuse, NY

Key facts

Inspection ID 1246771
Firm LOTTE Biologics USA, LLC
FEI number 1317757
Address 6000 Thompson Rd
City East Syracuse
State NY
ZIP 13057
Country United States
Fiscal year 2024
Inspection end date Sep 19, 2024
Classification No Action Indicated (NAI)
Project area Drug Quality Assurance
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

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