FDA Inspection
Covalon Technologies Ltd.Covalon Technologies Ltd. – FDA Inspection, Jan 18, 2018
Record Details
This FDA Inspection record concerns Covalon Technologies Ltd., with an inspection on January 18, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · cc5db8e5-9a55-492c-ac9d-45a197988a4d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1039040
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
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Other FDA inspections of Covalon Technologies Ltd.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 12, 2018 | Not classified | Office of Inspections and Investigations | |
| April 24, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Covalon Technologies Ltd.
- FDA Inspection 1132036 - 2018-09-12
- FDA Inspection 882734 - 2014-04-24
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