FDA Inspection
Cosmed of New JerseyFDA Inspection 1313802 - Cosmed of New Jersey - April 24, 2026
Record Details
This FDA Inspection record concerns Cosmed of New Jersey, with an inspection on April 24, 2026, issued by the New Jersey District Office.
- Company
- Cosmed of New Jersey
- Inspection Date
- April 24, 2026
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ID · 43cb9660-79ca-4c4c-949f-e6fbe34054ea
Inspection Facts
- Inspection number
- 1313802
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
2- ISO 13485:2016 Clause 7.1Product realization risk management processes not documented
- ISO 13485:2016 Clause 8.3.1Procedure for nonconforming product not documented
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Other FDA inspections of Cosmed of New Jersey
5| Date | Classification | Office | Project area |
|---|---|---|---|
| June 8, 2023 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 19, 2019 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 20, 2017 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| October 28, 2014 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 18, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Cosmed of New Jersey
- FDA Inspection 1208476 - 2023-06-08
- FDA Inspection 1123230 - 2019-12-19
- FDA Inspection 1011474 - 2017-04-20
- FDA Inspection 902142 - 2014-10-28
- FDA Inspection 740406 - 2011-08-18
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