Orca1

FDA inspection

Custom Ultrasonics, Inc.: FDA inspection ending Sep 23, 2021

FDA inspection 1156587 · Ivyland, PA

Key facts

Inspection ID 1156587
Firm Custom Ultrasonics, Inc.
FEI number 2523209
Address 144 Railroad Dr
City Ivyland
State PA
ZIP 18974-1449
Fiscal year 2021
Inspection end date Sep 23, 2021
Project area Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices
Product type Devices

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.

Other inspections at this establishment

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