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FDA Inspection
•Euclid Systems Corporation•August 15, 2025

Euclid Systems Corporation – FDA Inspection, Aug 15, 2025

Record Details

This FDA Inspection record concerns Euclid Systems Corporation, with an inspection on August 15, 2025, issued by the Baltimore District Office, covering medical devices & rad health.

Company
Euclid Systems Corporation
Inspection Date
August 15, 2025
Product Type
Medical Devices & Rad Health
Office
Baltimore District Office
Person
  • Tiki Dixon
View Company Profile

ID · 91926129-9b54-4422-8339-195064345400

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
1280137
FDA center
Medical Devices & Rad Health
Project area
Compliance: Medical Devices
Outcome
Form 483 issued, view the record

FDA Citations

3
  1. 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
  2. 21 CFR 820.198(a)Lack of or inadequate complaint procedures
  3. 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Euclid Systems Corporation

3
DateClassificationOfficeProject area
February 21, 2019NAICenter for Devices and Radiological HealthPostmarket Assurance: Devices
March 7, 2018OAICenter for Devices and Radiological HealthProject Evaluation: Devices
February 11, 2016NAICenter for Devices and Radiological HealthCompliance: Devices
Other documents for Euclid Systems Corporation
  • FDA Inspection 1085161 - 2019-02-21
  • FDA Inspection 1043716 - 2018-03-07
  • FDA Inspection 961834 - 2016-02-11

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