FDA Inspection
Ocusun, LLCOcusun, LLC – FDA Inspection, Jan 29, 2009
Record Details
This FDA Inspection record concerns Ocusun, LLC, with an inspection on January 29, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Ocusun, LLC
- Inspection Date
- January 29, 2009
- Product Type
- Devices
View Company Profile
ID · 23dc74d6-b216-4ac6-bb37-c0e99a6b72c8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 556138
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.20(d)Quality plan
- 21 CFR 820.198(a)General
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.160(a)Control/distribution procedures
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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 |
| July 6, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Ocusun, LLC
- FDA Inspection 967464 - 2015-12-15
- FDA Inspection 605251 - 2009-07-06
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