FDA Inspection
Ophtec BVOphtec BV – FDA Inspection, Mar 23, 2017
Record Details
This FDA Inspection record concerns Ophtec BV, with an inspection on March 23, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 4af7d630-b354-413f-8e73-374a73830b97
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1008948
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
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