FDA Inspection
Core Health and Fitness, LLCCore Health and Fitness, LLC – FDA Inspection, Jul 30, 2026
Record Details
This FDA Inspection record concerns Core Health and Fitness, LLC, with an inspection on July 30, 2026, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · 4e36a9ea-183d-4f5f-a49e-480b6b1ee0a9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1328630
- Project area
- Compliance: Devices
FDA Citations
4- ISO 13485:2016 Clause 7.3.10Procedures to control design and development changes not documented
- ISO 13485:2016 Clause 4.1.3Inadequate monitoring and control over outsourced processes
- ISO 13485:2016 Clause 4.1.5Inadequate monitoring and control over outsourced processes
- ISO 13485:2016 Clause 7.3.9Procedures to control design and development changes not documented
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Core Health and Fitness, LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| September 11, 2025 | NAI | Baltimore District Office | Postmarket Assurance: Medical Devices |
| November 8, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 11, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Core Health and Fitness, LLC
- FDA Inspection 1283682 - 2025-09-11
- FDA Inspection 1032544 - 2017-11-08
- FDA Inspection 895740 - 2014-09-11
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.