Company
Dominican Republic (the)Oscor Caribe, LLC, Santo Domingo, Dominican Republic (the) – FDA Inspections
Inspection records and compliance data for Oscor Caribe, LLC in Santo Domingo. 6 FDA inspections on record, last inspected August 22, 2025.
Company Profile
This profile covers Oscor Caribe, LLC based in Santo Domingo, Dominican Republic (the).
FDA Inspection History
- FDA inspections
- 6
- OAI
- 0
- VAI
- 3
- NAI
- 3
- Form 483s
- 0
- Warning letters
- 0
First inspected June 25, 2009. Last inspected August 22, 2025.
Most cited issue areas
- Documentation1 inspection
- Documentation of validated process performance1 inspection
- Lack of or inadequate procedures1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 22, 2025 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1300732 |
| January 18, 2023 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1199358 |
| December 11, 2019 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1114423 |
| July 25, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 841836 |
| August 19, 2011 | VAI | Medical Devices & Rad Health · Compliance: Devices | 749326 |
| June 25, 2009 | VAI | Medical Devices & Rad Health · Compliance: Devices | 594560 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Oscor Caribe, LLC
FEI Number
3004785273
Address
Zona Franca Las Americas, Nave I-2, Autopista Las Americas Km 22, Santo Domingo, Dominican Republic (the)
Country
Dominican Republic (the)
ID: cc991e26-cbcf-439f-8897-b2c664cbc13c