FDA Inspection
Shalon Chemical Industries Ltd.Shalon Chemical Industries Ltd. – FDA Inspection, Oct 13, 2016
Record Details
This FDA Inspection record concerns Shalon Chemical Industries Ltd., with an inspection on October 13, 2016, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Inspection Date
- October 13, 2016
- Product Type
- Medical Devices & Rad Health
- Person
- Arie Menachem (Issuing Officer)
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ID · 22d48dde-d743-4d7b-aa95-77a3e3838a8f
Inspection Facts
- Inspection number
- 988933
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.250(b)Sampling methods - Lack of or inadequate procedures
- 21 CFR 820.72(b)Calibration procedures - content
- 21 CFR 820.75(a)Lack of or inadequate process validation
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Other FDA inspections of Shalon Chemical Industries Ltd.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 20, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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