FDA Inspection
Ophthalmic Imaging SystemsOphthalmic Imaging Systems – FDA Inspection, Mar 25, 2011
Record Details
This FDA Inspection record concerns Ophthalmic Imaging Systems, with an inspection on March 25, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Ophthalmic Imaging Systems
- Inspection Date
- March 25, 2011
- Product Type
- Devices
View Company Profile
ID · 9ecd7dd3-096e-43bc-92b5-7a9605f9dd61
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 716220
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.100(b)Documentation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.250(b)Sampling methods - Lack of or inadequate procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
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.