FDA inspection

Hologic, Inc.: FDA inspection ending Oct 14, 2022

FDA inspection 1181513 · Official Action Indicated (OAI) · San Diego, CA

Key facts

Inspection ID 1181513
Firm Hologic, Inc.
FEI number 2024800
Address 10210 Genetic Center Dr
City San Diego
State CA
ZIP 92121
Country United States
Fiscal year 2023
Inspection end date Oct 14, 2022
Classification Official Action Indicated (OAI)
Project area Compliance: Devices
Product type Devices

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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