FDA Inspection
Core Health and Fitness, LLCCore Health and Fitness, LLC – FDA Inspection, Sep 11, 2025
Record Details
This FDA Inspection record concerns Core Health and Fitness, LLC, with an inspection on September 11, 2025, issued by the Baltimore District Office, covering medical devices & rad health.
- Company
- Core Health and Fitness, LLC
- Inspection Date
- September 11, 2025
- Product Type
- Medical Devices & Rad Health
- Person
View Company Profile
ID · 7322eab7-72f7-4ecc-89b5-5ab869e4eb48
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1283682
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Medical Devices
FDA Citations
6- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.30(g)Design validation - software validation not performed
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
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 |
|---|---|---|---|
| July 30, 2026 | VAI | Center for Devices and Radiological Health | Compliance: 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 1328630 - 2026-07-30
- FDA Inspection 1032544 - 2017-11-08
- FDA Inspection 895740 - 2014-09-11
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