Company
United StatesSmiths Medical ASD, Inc., Minneapolis, MN – FDA Inspections
Inspection records and compliance data for Smiths Medical ASD, Inc. in Minneapolis, Minnesota. 4 FDA inspections on record (1 OAI), 1 Form 483, last inspected August 09, 2024.
Company Profile
This profile covers Smiths Medical ASD, Inc. based in Minneapolis, Minnesota, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 1
- VAI
- 1
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected October 12, 2017. Last inspected August 9, 2024.
Most cited issue areas
- Lack of or inadequate procedures2 inspections
- Design history file1 inspection
- Design input - Lack of or inadequate procedures1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 9, 2024 | Not classified | Medical Devices & Rad Health | 1239757 |
| March 3, 2023 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1201170 |
| April 30, 2021 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1141758 |
| October 12, 2017 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1029368 |
FDA documents
Form 483s (2)
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Company Information
Name
Smiths Medical ASD, Inc.
FEI Number
3012307300
Address
6000 Nathan Ln N, Minneapolis, Minnesota 55442, United States
Country
United States
ID: e574d600-79d9-4efb-b599-8520f202268a