FDA Inspection
Garaventa (Canada), Ltd.Garaventa (Canada), Ltd. – FDA Inspection, Jan 18, 2018
Record Details
This FDA Inspection record concerns Garaventa (Canada), Ltd., with an inspection on January 18, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · af50309f-d921-40de-ab01-9223c7108690
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1038581
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(c)Design input - Lack of or inadequate procedures
- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 820.30(g)Design validation - Risk analysis
- 21 CFR 820.70(i)Software validation for automated processes
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Other FDA inspections of Garaventa (Canada), Ltd.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| May 9, 2024 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 6, 2012 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
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