FDA Inspection
Integrated Ophthalmic Systems, IncIntegrated Ophthalmic Systems, Inc – FDA Inspection, Dec 15, 2021
Record Details
This FDA Inspection record concerns Integrated Ophthalmic Systems, Inc, with an inspection on December 15, 2021, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- December 15, 2021
- Product Type
- Devices
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ID · f8cf58a7-b4ba-4289-a221-24c9101493a0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1158825
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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