Company
United KingdomSmiths Medical International Limited, Luton, United Kingdom – FDA Inspections
Inspection records and compliance data for Smiths Medical International Limited in Luton. 2 FDA inspections on record, 1 Form 483, last inspected June 07, 2018.
Company Profile
This profile covers Smiths Medical International Limited based in Luton, United Kingdom.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 0
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected November 19, 2015. Last inspected June 7, 2018.
Most cited issue areas
- Design validation - Risk analysis1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 7, 2018 | Not classified | Medical Devices & Rad Health · Compliance: Devices | 1055067 |
| November 19, 2015 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 950811 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Smiths Medical International Limited
FEI Number
3002809579
Address
Bramingham Business Park, Enterprise Way, Luton, United Kingdom
Country
United Kingdom
ID: 9381fcf2-3690-4bbf-b8f0-75fbb70c0f98