Company
United KingdomLeica Biosystems Newcastle Ltd., Newcastle Upon Tyne, United Kingdom – FDA Inspections
Inspection records and compliance data for Leica Biosystems Newcastle Ltd. in Newcastle Upon Tyne. 4 FDA inspections on record, 2 Form 483s, last inspected January 25, 2019.
Company Profile
This profile covers Leica Biosystems Newcastle Ltd. based in Newcastle Upon Tyne, United Kingdom.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 2
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 2
- Warning letters
- 0
First inspected November 5, 2009. Last inspected January 25, 2019.
Most cited issue areas
- Lack of or inadequate procedures1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| January 25, 2019 | Not classified | Medical Devices & Rad Health | 1093975 |
| April 27, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1016878 |
| June 5, 2014 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 883111 |
| November 5, 2009 | VAI | Medical Devices & Rad Health · Compliance: Devices | 629656 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Leica Biosystems Newcastle Ltd.
FEI Number
3004859032
Address
Balliol Business Park, Benton Lane, Newcastle Upon Tyne, United Kingdom
Country
United Kingdom
ID: b2f3453d-9261-46b6-9455-f1fe00be5a5a