FDA Inspection
RANDOX TEORANTARANDOX TEORANTA – FDA Inspection, Jun 7, 2018
Record Details
This FDA Inspection record concerns RANDOX TEORANTA, with an inspection on June 7, 2018, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Person
- Lisa A. Stura (Issuing Officer)
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ID · c0bcb1f6-9c10-4abf-87ec-482a928e9593
Inspection Facts
- Inspection number
- 1054635
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 1002.10Failure to submit, distinct marking
- 21 CFR 1002.13Failure to submit
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
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Other FDA inspections of RANDOX TEORANTA
1| Date | Classification | Office | Project area |
|---|---|---|---|
| December 5, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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