FDA Inspection
Ophtec USA, Inc.FDA Inspection 1173082 - Ophtec USA, Inc. - June 24, 2022
Record Details
This FDA Inspection record concerns Ophtec USA, Inc., with an inspection on June 24, 2022, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Ophtec USA, Inc.
- Inspection Date
- June 24, 2022
- Product Type
- Devices
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ID · f35b752b-bf0d-4e2e-a26e-5735b498a25d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1173082
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
1- 21 CFR 812.150(b)(4)No 6-month sponsor reports of current investigators
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