FDA Inspection
Immuno Concepts, N.A., LtdImmuno Concepts, N.A., Ltd – FDA Inspection, Apr 9, 2019
Record Details
This FDA Inspection record concerns Immuno Concepts, N.A., Ltd, with an inspection on April 9, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · caa1b662-6a4a-4eb5-8256-9b68e2572b15
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1085802
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
- 21 CFR 820.22Quality Audits - defined intervals
- 21 CFR 820.70(i)Software validation for automated processes
- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
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