FDA Inspection
Smiths Medical International Ltd.Smiths Medical International Ltd. – FDA Inspection, Dec 10, 2009
Record Details
This FDA Inspection record concerns Smiths Medical International Ltd., with an inspection on December 10, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- December 10, 2009
- Product Type
- Devices
View Company Profile
ID · 2237f3cc-737a-4563-b625-38eaf383accf
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 634587
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
8- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.198(a)(1)Uniform and timely processing
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.184DHR content
- 21 CFR 820.100(b)Procedures
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