FDA Inspection
Oscor Caribe, LLCOscor Caribe, LLC – FDA Inspection, Aug 19, 2011
Record Details
This FDA Inspection record concerns Oscor Caribe, LLC, with an inspection on August 19, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Oscor Caribe, LLC
- Inspection Date
- August 19, 2011
- Product Type
- Devices
View Company Profile
ID · 1f87cf51-48f1-4fc6-a288-94b3ac2c285f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 749326
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.75(a)Documentation
- 21 CFR 820.75(b)(2)Documentation of validated process performance
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Oscor Caribe, LLC
5| Date | Classification | Office | Project area |
|---|---|---|---|
| August 22, 2025 | NAI | Compliance: Devices | |
| January 18, 2023 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 11, 2019 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 25, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 25, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Oscor Caribe, LLC
- FDA Inspection 1300732 - 2025-08-22
- FDA Inspection 1199358 - 2023-01-18
- FDA Inspection 1114423 - 2019-12-11
- FDA Inspection 841836 - 2013-07-25
- FDA Inspection 594560 - 2009-06-25
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.