FDA Inspection
Euclid Systems CorporationEuclid Systems Corporation – FDA Inspection, Mar 7, 2018
Record Details
This FDA Inspection record concerns Euclid Systems Corporation, with an inspection on March 7, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · bcead8e7-4c05-4344-b35c-dd0f44ca1718
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1043716
- FDA center
- Medical Devices & Rad Health
- Project area
- Project Evaluation: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.75(a)Lack of or inadequate process validation
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Other FDA inspections of Euclid Systems Corporation
3| Date | Classification | Office | Project area |
|---|---|---|---|
| August 15, 2025 | VAI | Baltimore District Office | Compliance: Medical Devices |
| February 21, 2019 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| February 11, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Euclid Systems Corporation
- FDA Inspection 1280137 - 2025-08-15
- FDA Inspection 1085161 - 2019-02-21
- FDA Inspection 961834 - 2016-02-11
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