Company
United StatesOrthobone, Inc., San Juan, PR – FDA Inspections
Inspection records and compliance data for Orthobone, Inc. in San Juan, Puerto Rico. 5 FDA inspections on record, last inspected June 18, 2024.
Company Profile
This profile covers Orthobone, Inc. based in San Juan, Puerto Rico, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 2
- NAI
- 3
- Form 483s
- 0
- Warning letters
- 0
First inspected March 2, 2012. Last inspected June 18, 2024.
Most cited issue areas
- Procedures to meet core CTGP1 inspection
- Return to inventory--procedures1 inspection
- Shipping conditions appropriate1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 18, 2024 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 1242170 |
| January 15, 2020 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 1115375 |
| August 16, 2018 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 1065410 |
| May 4, 2016 | VAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 970058 |
| March 2, 2012 | VAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 770808 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Orthobone, Inc.
FEI Number
3008410332
Address
#202 Federico Costas Street, Urb Industrial Tres Monjitas, San Juan, Puerto Rico 00918, United States
Country
United States
ID: 66612f36-c0ae-4f86-87a5-5d4bef71caa6