Company
United KingdomGlaxo Operations U.K. Ltd., Barnard Castle, United Kingdom – FDA Inspections
Inspection records and compliance data for Glaxo Operations U.K. Ltd. in Barnard Castle. 11 FDA inspections on record, 4 Form 483s, last inspected March 16, 2023.
Company Profile
This profile covers Glaxo Operations U.K. Ltd. based in Barnard Castle, United Kingdom.
FDA Inspection History
- FDA inspections
- 11
- OAI
- 0
- VAI
- 8
- NAI
- 1
- Unclassified
- 2
- Form 483s
- 4
- Warning letters
- 0
First inspected December 18, 2008. Last inspected March 16, 2023.
Most cited issue areas
- Absence of Written Procedures1 inspection
- Cleaning / Sanitizing / Maintenance1 inspection
- Defined areas of adequate size for operations1 inspection
FDA inspections (11)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 16, 2023 | Not classified | Human Drugs | 1211398 |
| February 10, 2023 | VAI | Human Drugs · Drug Quality Assurance | 1209851 |
| September 17, 2019 | VAI | Human Drugs · New Drug Evaluation | 1107134 |
| July 4, 2017 | Not classified | Human Drugs | 1016930 |
| June 2, 2017 | VAI | Human Drugs · Drug Quality Assurance | 1014765 |
| June 23, 2015 | VAI | Human Drugs · Drug Quality Assurance | 933676 |
| May 9, 2013 | VAI | Human Drugs · Drug Quality Assurance | 831335 |
| September 22, 2011 | VAI | Human Drugs · Drug Quality Assurance | 746871 |
| November 1, 2010 | VAI | Human Drugs · Drug Quality Assurance | 698025 |
| May 22, 2009 | NAI | Human Drugs · Drug Quality Assurance | 597648 |
| December 18, 2008 | VAI | Human Drugs · Drug Quality Assurance | 559582 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Glaxo Operations U.K. Ltd.
FEI Number
3002807078
Address
Harmire Road, Barnard Castle, United Kingdom
Country
United Kingdom
ID: 5c8a39c9-a63a-4574-885a-c16948f20589