FDA Inspection
ROCAMED SAMROCAMED SAM – FDA Inspection, May 16, 2024
Record Details
This FDA Inspection record concerns ROCAMED SAM, with an inspection on May 16, 2024, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · 8bc59e21-fa17-47a9-bef4-418fa989e494
Inspection Facts
- Inspection number
- 1241389
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 803.17(a)(3)Lack of System for Timely Submission of Reports
- 21 CFR 820.184DHR content
- 21 CFR 820.198(a)Complaints
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
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