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FDA Inspection
•Ulrich Medical USA Inc•March 17, 2025

Ulrich Medical USA Inc – FDA Inspection, Mar 17, 2025

Record Details

This FDA Inspection record concerns Ulrich Medical USA Inc, with an inspection on March 17, 2025, issued by the Dallas District Office, covering medical devices & rad health.

Company
Ulrich Medical USA Inc
Inspection Date
March 17, 2025
Product Type
Medical Devices & Rad Health
Office
Dallas District Office
Person
  • Jacey Roy (Investigator)
View Company Profile

ID · 8e89dab0-1844-4b19-af64-f8e746c22239

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
1264134
FDA center
Medical Devices & Rad Health
Project area
Compliance: Medical Devices
Outcome
Form 483 issued, view the record

FDA Citations

1
  1. 21 CFR 820.198(a)Lack of or inadequate complaint procedures

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Ulrich Medical USA Inc

3
DateClassificationOfficeProject area
March 6, 2019VAICenter for Devices and Radiological HealthPostmarket Assurance: Devices
January 12, 2017VAICenter for Devices and Radiological HealthCompliance: Devices
February 25, 2010NAICenter for Devices and Radiological HealthPostmarket Assurance: Devices
Other documents for Ulrich Medical USA Inc
  • FDA Inspection 1083130 - 2019-03-06
  • FDA Inspection 998483 - 2017-01-12
  • FDA Inspection 649521 - 2010-02-25

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