FDA inspection

RESET TECHNOLOGY CORPORATION: FDA inspection ending Dec 20, 2024

FDA inspection 1257116 · Official Action Indicated (OAI) · Englewood Cliffs, NJ

Key facts

Inspection ID 1257116
Firm RESET TECHNOLOGY CORPORATION
FEI number 3030254128
Address 300 Sylvan Ave
City Englewood Cliffs
State NJ
ZIP 07632
Country United States
Fiscal year 2025
Inspection end date Dec 20, 2024
Classification Official Action Indicated (OAI)
Project area Postmarket Assurance: Devices
Product type Devices
Warning letter 704828

At a glance

  • 10–99 Citations
  • 1–9 Posted citations
  • Yes Warning letter followed
  • Yes Form FDA 483 issued
  • No 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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