FDA Inspection
Paragon 28, Inc.Paragon 28, Inc. – FDA Inspection, Apr 24, 2025
Record Details
This FDA Inspection record concerns Paragon 28, Inc., with an inspection on April 24, 2025, issued by the Denver District Office, covering medical devices & rad health.
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ID · 316c7fe7-3f11-4eb8-b033-73d946eb0bf8
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1267823
- FDA center
- Medical Devices & Rad Health
- Project area
- Product Evaluation: Medical Devices
FDA Citations
2- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Paragon 28, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| July 13, 2023 | NAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
| June 29, 2022 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| April 18, 2017 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| November 26, 2013 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Paragon 28, Inc.
- FDA Inspection 1214506 - 2023-07-13
- FDA Inspection 1176976 - 2022-06-29
- FDA Inspection 1007606 - 2017-04-18
- FDA Inspection 856673 - 2013-11-26
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