FDA Inspection
Sweden & Martina SpaSweden & Martina Spa – FDA Inspection, Aug 1, 2024
Record Details
This FDA Inspection record concerns Sweden & Martina Spa, with an inspection on August 1, 2024, issued by the Center for Devices and Radiological Health, covering devices.
- Person
- Melissa A. Zuppe
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ID · 5276d8d3-409e-48b9-9355-78a1a6234b4b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1249532
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.50(a)(3)Acceptable supplier records, inadequate records
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