FDA Inspection
Shalon Chemical Industries Ltd.Shalon Chemical Industries Ltd. – FDA Inspection, Nov 20, 2017
Record Details
This FDA Inspection record concerns Shalon Chemical Industries Ltd., with an inspection on November 20, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · eea57881-5af6-4c9e-96a9-6530de582b10
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1032158
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 211.80(a)Procedures To Be in Writing
- 21 CFR 803.17Lack of Written MDR Procedures
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule
- 21 CFR 820.75(a)Documentation
- 21 CFR 820.80(c)Lack of or inadequate In-process acceptance procedures
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Other FDA inspections of Shalon Chemical Industries Ltd.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| October 13, 2016 | Not classified | Office of Inspections and Investigations | Compliance: Devices |
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