FDA Inspection
SMICNA PTE LTDSMICNA PTE LTD – FDA Inspection, May 30, 2024
Record Details
This FDA Inspection record concerns SMICNA PTE LTD, with an inspection on May 30, 2024, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · 2cfc43f3-a064-434c-8b91-785b53185dfb
Inspection Facts
- Inspection number
- 1240396
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.75(a)Lack of or inadequate process validation
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