FDA Inspection
SMITHS MEDICAL ITALIA SRLSMITHS MEDICAL ITALIA SRL – FDA Inspection, May 26, 2016
Record Details
This FDA Inspection record concerns SMITHS MEDICAL ITALIA SRL, with an inspection on May 26, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- SMITHS MEDICAL ITALIA SRL
- Inspection Date
- May 26, 2016
- Product Type
- Devices
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ID · cf2d3899-7c93-4166-8355-a4e8532a27a6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 976710
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
- 21 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
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Other FDA inspections of SMITHS MEDICAL ITALIA SRL
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 2, 2023 | Not classified | Office of Inspections and Investigations | |
| November 8, 2018 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for SMITHS MEDICAL ITALIA SRL
- FDA Inspection 1203860 - 2023-03-02
- FDA Inspection 1074879 - 2018-11-08
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