FDA Inspection
77 Elektronika Kft.77 Elektronika Kft. – FDA Inspection, Nov 8, 2018
Record Details
This FDA Inspection record concerns 77 Elektronika Kft., with an inspection on November 8, 2018, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · be7ff0f3-567c-4674-83c5-248bfc46c377
Inspection Facts
- Inspection number
- 1071385
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.70(g)(2)Periodic equipment inspection lack of or inadequate procedu
- 21 CFR 820.75(a)Lack of or inadequate process validation
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Other FDA inspections of 77 Elektronika Kft.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 12, 2015 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
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