FDA Inspection
Ocusun, LLCOcusun, LLC – FDA Inspection, Jul 6, 2009
Record Details
This FDA Inspection record concerns Ocusun, LLC, with an inspection on July 6, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Ocusun, LLC
- Inspection Date
- July 6, 2009
- Product Type
- Devices
View Company Profile
ID · 90640a09-a787-4395-a125-5a450e98b514
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 605251
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 820.100(a)(2)Investigation
- 21 CFR 820.198(b)Review and evaluation for investigation
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
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Other FDA inspections of Ocusun, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| December 15, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 29, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Ocusun, LLC
- FDA Inspection 967464 - 2015-12-15
- FDA Inspection 556138 - 2009-01-29
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