FDA Inspection
DiaSource ImmunoAssays, SADiaSource ImmunoAssays, SA – FDA Inspection, Jun 7, 2018
Record Details
This FDA Inspection record concerns DiaSource ImmunoAssays, SA, with an inspection on June 7, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 82d9cda6-c06a-459f-9714-7d525ba2e1f4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1054641
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.70(f)Buildings
- 21 CFR 820.120(b)Examination for accuracy
- 21 CFR 820.150Lack of or inadequate procedures for storage.
- 21 CFR 820.70(i)Software validation for automated processes
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