FDA Inspection
Seodong Medical CoSeodong Medical Co – FDA Inspection, May 3, 2018
Record Details
This FDA Inspection record concerns Seodong Medical Co, with an inspection on May 3, 2018, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · 9fbbef23-f2d0-4a11-ab3d-bcf958ae6bd5
Inspection Facts
- Inspection number
- 1050565
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
10- 21 CFR 803.17Lack of Written MDR Procedures
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.120Lack of or inadequate procedures for labeling
- 21 CFR 820.120(d)Records, DHR {see also 820.184(e)}
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.30(c)Design input - documentation
- 21 CFR 820.30(g)Design validation acceptance criteria
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.80(e)Documentation
- 21 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
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