CALVARY SPINE, LLC — FDA Facility Profile
CALVARY SPINE, LLC is an FDA-registered facility (FEI 3007279845) located in Towson, MD, US. RegDataLab tracks 5 FDA inspections at this facility.
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What FDA found at this site
- Latest inspection
- May 2, 2025: No Action Indicated (NAI)
- Inspections on record
- 5 (2 VAI, 3 NAI)
- Last OAI inspection
- None on record
- Warning letters
- None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| May 2, 2025 | No Action Indicated (NAI) | No citations listed |
| Jan 25, 2018 | Voluntary Action Indicated (VAI) | Training - Lack of or inadequate procedures (21 CFR 820.25(b)) Lack of or inadequate procedures (21 CFR 820.100(a)) Design Validation - Risk analysis not performed/inadequate (21 CFR 820.30(g)) Purchasing controls, Lack of or inadequate procedures (21 CFR 820.50) |
| Jan 29, 2016 | No Action Indicated (NAI) | No citations listed |
| Mar 21, 2013 | Voluntary Action Indicated (VAI) | Design verification - Lack of or inadequate procedures (21 CFR 820.30(f)) Design validation- Lack of or inadequate procedures (21 CFR 820.30(g)) |
| Mar 11, 2010 | No Action Indicated (NAI) | No citations listed |
Facility details
- Company
- Calvary Spine, LLC
- Location
- Towson, MD (US)
- Source
- device