FDA Inspection
Cosmed of New JerseyFDA Inspection 1208476 - Cosmed of New Jersey - June 08, 2023
Record Details
This FDA Inspection record concerns Cosmed of New Jersey, with an inspection on June 8, 2023, issued by the Center for Devices and Radiological Health, covering devices.
- People
- Frank J. Marciniak (Issuing Officer)
- Melissa A. Zuppe
- Naakesh N. Gomanie
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ID · ce1b9e5c-0bb6-4aa7-8372-280769559a17
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1208476
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Cosmed of New Jersey
5| Date | Classification | Office | Project area |
|---|---|---|---|
| April 24, 2026 | Not classified | New Jersey District Office | 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 1313802 - 2026-04-24
- 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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