AstraZeneca UK Ltd — FDA Facility Profile
AstraZeneca UK Ltd is an FDA-registered facility (FEI 3002850317) located in Macclesfield, GB. Registered operations: ANALYSIS; LABEL; MANUFACTURE; PACK. RegDataLab tracks 6 FDA inspections at this facility.
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What FDA found at this site
- Latest inspection
- Apr 27, 2023: Voluntary Action Indicated (VAI)
- Inspections on record
- 6 (5 VAI, 1 NAI)
- Last OAI inspection
- None on record
- Warning letters
- None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
- Import refusals
- 10 or more
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Apr 27, 2023 | Voluntary Action Indicated (VAI) | No citations listed |
| Feb 23, 2020 | Voluntary Action Indicated (VAI) | No citations listed |
| Apr 13, 2017 | No Action Indicated (NAI) | No citations listed |
| Apr 11, 2014 | Voluntary Action Indicated (VAI) | No citations listed |
| Mar 16, 2012 | Voluntary Action Indicated (VAI) | Procedures for sterile drug products (21 CFR 211.113(b)) Written record of investigation incomplete (21 CFR 211.192) |
| Aug 14, 2009 | Voluntary Action Indicated (VAI) | No citations listed |
Facility details
- Company
- AstraZeneca UK Ltd.
- Location
- Macclesfield (GB)
- Registration Expires
- Dec 31, 2027
- Operations
- ANALYSIS; LABEL; MANUFACTURE; PACK
- Source
- decrs