Company
United KingdomSMITH & NEPHEW ORTHOPAEDICS LTD., Leamington Spa, United Kingdom – FDA Inspections
Inspection records and compliance data for SMITH & NEPHEW ORTHOPAEDICS LTD. in Leamington Spa. 3 FDA inspections on record, 1 Form 483, last inspected February 15, 2018.
Company Profile
This profile covers SMITH & NEPHEW ORTHOPAEDICS LTD. based in Leamington Spa, United Kingdom.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 2
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected January 21, 2010. Last inspected February 15, 2018.
Most cited issue areas
- Lack of or inadequate process validation1 inspection
- Lack of or inadequate receiving acceptance procedures1 inspection
- Nonconforming product, Lack of or inadequate procedures1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 15, 2018 | VAI | Medical Devices & Rad Health · Bioresearch Monitoring | 1042425 |
| May 15, 2014 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 883436 |
| January 21, 2010 | VAI | Medical Devices & Rad Health · Bioresearch Monitoring | 644582 |
FDA documents
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Company Information
Name
SMITH & NEPHEW ORTHOPAEDICS LTD.
FEI Number
3005975929
Address
Aurora, Spa Park, Harrison Way, Leamington Spa, United Kingdom
Country
United Kingdom
ID: 3776950e-312d-40a7-a0f5-019c57242f23