FDA Inspection
FABRINAL SAFABRINAL SA – FDA Inspection, Dec 7, 2017
Record Details
This FDA Inspection record concerns FABRINAL SA, with an inspection on December 7, 2017, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · c04ddb90-925c-4d95-be64-6e53e7a8eb53
Inspection Facts
- Inspection number
- 1036166
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
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Other FDA inspections of FABRINAL SA
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 9, 2023 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for FABRINAL SA
- FDA Inspection 1203861 - 2023-03-09
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