FDA Inspection
SIGVARIS DO BRASIL IND. E COM. LTDASIGVARIS DO BRASIL IND. E COM. LTDA – FDA Inspection, Sep 6, 2012
Record Details
This FDA Inspection record concerns SIGVARIS DO BRASIL IND. E COM. LTDA, with an inspection on September 6, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- September 6, 2012
- Product Type
- Devices
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ID · b1ccf2d2-dc0f-42a1-8b87-a8852d54caef
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 800343
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.72(a)Equipment control activity documentation
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
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Other FDA inspections of SIGVARIS DO BRASIL IND. E COM. LTDA
3| Date | Classification | Office | Project area |
|---|---|---|---|
| March 7, 2024 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 16, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 4, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for SIGVARIS DO BRASIL IND. E COM. LTDA
- FDA Inspection 1235488 - 2024-03-07
- FDA Inspection 1012425 - 2017-03-16
- FDA Inspection 912876 - 2015-02-04
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