Company
United KingdomAstraZeneca UK Ltd., Macclesfield, United Kingdom – FDA Inspections
Inspection records and compliance data for AstraZeneca UK Ltd. in Macclesfield. 7 FDA inspections on record, 1 Form 483, last inspected April 27, 2023.
Company Profile
This profile covers AstraZeneca UK Ltd. based in Macclesfield, United Kingdom.
FDA Inspection History
- FDA inspections
- 7
- OAI
- 0
- VAI
- 5
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected August 14, 2009. Last inspected April 27, 2023.
Most cited issue areas
- Procedures for sterile drug products1 inspection
- Written record of investigation incomplete1 inspection
FDA inspections (7)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 27, 2023 | VAI | Human Drugs · Drug Quality Assurance | 1274179 |
| February 23, 2020 | VAI | Human Drugs · Drug Quality Assurance | 1129231 |
| September 22, 2017 | Not classified | Human Drugs | 1030226 |
| April 13, 2017 | NAI | Human Drugs · Drug Quality Assurance | 1017549 |
| April 11, 2014 | VAI | Human Drugs · Drug Quality Assurance | 878183 |
| March 16, 2012 | VAI | Human Drugs · Drug Quality Assurance | 785250 |
| August 14, 2009 | VAI | Human Drugs · Drug Quality Assurance | 612417 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Other regulators (1)
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Company Information
Name
AstraZeneca UK Ltd.
FEI Number
3002850317
Address
Charter Way, Silk Road Business Park, Macclesfield, United Kingdom
Country
United Kingdom
ID: d28c6a70-76f3-49fb-a3c2-bc412f662941