FDA Inspection
Smiths Medical ASD, Inc.Smiths Medical ASD, Inc. – FDA Inspection, Apr 30, 2021
Record Details
This FDA Inspection record concerns Smiths Medical ASD, Inc., with an inspection on April 30, 2021, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Smiths Medical ASD, Inc.
- Inspection Date
- April 30, 2021
- Product Type
- Devices
View Company Profile
ID · cc23944d-1787-4695-b1a7-aada8c357e01
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1141758
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
8- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(c)Design input - Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.198(e)Maintained
- 21 CFR 820.30(g)Design validation - Risk analysis
- 21 CFR 820.30(j)Design history file
- 21 CFR 803.17(a)(2)Lack of System for Determining MDR Events
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Smiths Medical ASD, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| August 9, 2024 | Not classified | Minneapolis District Office | |
| March 3, 2023 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 12, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Smiths Medical ASD, Inc.
- FDA Inspection 1239757 - 2024-08-09
- FDA Inspection 1201170 - 2023-03-03
- FDA Inspection 1029368 - 2017-10-12
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