Company
United KingdomLonza Biologics Plc, Slough, United Kingdom – FDA Inspections
Inspection records and compliance data for Lonza Biologics Plc in Slough. 6 FDA inspections on record, 2 Form 483s, last inspected October 13, 2022.
Company Profile
This profile covers Lonza Biologics Plc based in Slough, United Kingdom.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 0
- VAI
- 4
- NAI
- 0
- Unclassified
- 2
- Form 483s
- 2
- Warning letters
- 0
First inspected September 24, 2012. Last inspected October 13, 2022.
Most cited issue areas
- Cleaning System1 inspection
- Environmental Monitoring System1 inspection
- Investigations of discrepancies, failures1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| October 13, 2022 | VAI | Human Drugs · Drug Quality Assurance | 1202907 |
| September 28, 2018 | Not classified | Human Drugs | 1070651 |
| September 5, 2018 | VAI | Human Drugs · Drug Quality Assurance | 1097017 |
| March 31, 2017 | Not classified | Human Drugs | 1021064 |
| June 24, 2016 | VAI | Human Drugs · Drug Quality Assurance | 978909 |
| September 24, 2012 | VAI | Human Drugs · Drug Quality Assurance | 801062 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Other regulators (1)
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Company Information
Name
Lonza Biologics Plc
FEI Number
1000583959
Address
228 Bath Road, Slough, United Kingdom
Country
United Kingdom
ID: 9bb3cb06-cade-452a-ba25-b43fec0aaa12