FDA inspection

Macrogenics, Inc: FDA inspection ending Apr 6, 2021

FDA inspection 1140509 · Voluntary Action Indicated (VAI) · Rockville, MD

Key facts

Inspection ID 1140509
Firm Macrogenics, Inc
FEI number 3010195035
Address 9704 Medical Center Dr
City Rockville
State MD
ZIP 20850-3343
Fiscal year 2021
Inspection end date Apr 6, 2021
Classification Voluntary Action Indicated (VAI)
Project area New Drug Evaluation
Product type Drugs

At a glance

  • None Citations
  • 1–9 Posted citations
  • No Warning letter followed
  • Yes Form FDA 483 issued
  • Yes Establishment inspection report (EIR) exists
  • 1–9 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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