FDA Inspection
Silicone Ocular, LLCSilicone Ocular, LLC – FDA Inspection, Apr 19, 2013
Record Details
This FDA Inspection record concerns Silicone Ocular, LLC, with an inspection on April 19, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Silicone Ocular, LLC
- Inspection Date
- April 19, 2013
- Product Type
- Devices
View Company Profile
ID · b56ccd7f-78fe-4152-801b-e1f7f5428306
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 829008
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
8- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
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.