Company
United StatesCalvary Spine, LLC, Towson, MD – FDA Inspections
Inspection records and compliance data for Calvary Spine, LLC in Towson, Maryland. 5 FDA inspections on record, 1 Form 483, last inspected May 02, 2025.
Company Profile
This profile covers Calvary Spine, LLC based in Towson, Maryland, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 1
- NAI
- 4
- Form 483s
- 1
- Warning letters
- 0
First inspected March 11, 2010. Last inspected May 2, 2025.
Most cited issue areas
- Design Validation - Risk analysis not performed/inadequate1 inspection
- Lack of or inadequate procedures1 inspection
- Purchasing controls, Lack of or inadequate procedures1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 2, 2025 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1269031 |
| January 25, 2018 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1039010 |
| January 29, 2016 | NAI | Medical Devices & Rad Health · Compliance: Devices | 971034 |
| March 21, 2013 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 823500 |
| March 11, 2010 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 651527 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Calvary Spine, LLC
FEI Number
3007279845
Address
308 N Wind Rd, Towson, Maryland 21204, United States
Country
United States
ID: 4801ab8b-e2ad-47e5-b852-14eff0318cac