Home / Companies / AstraZeneca UK Ltd.

AstraZeneca UK Ltd.

FDA Regulatory Profile

AstraZeneca UK Ltd. has 0 FDA recalls, 6 inspections, 0 510(k) clearances and 0 compliance actions on record.

What these totals cover: FDA records filed under the name "AstraZeneca UK Ltd." and its spelling variant "Astrazeneca Uk".

Latest inspection
Apr 27, 2023 · VAI

Reviewing AstraZeneca UK Ltd. as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.

Check this supplier

Or check AstraZeneca UK Ltd. yourself in Claude, Cursor or ChatGPT: get the full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site.

Get a free API key

Is this your company or a supplier you list? Link to this FDA record from your site with a free button.

Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections6Nov 13, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

AstraZeneca UK Ltd.'s FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

AstraZeneca UK Ltd.: FDA inspections per year 2017: 1 inspections120172018: 0 inspections020182019: 0 inspections020192020: 1 inspections120202021: 0 inspections020212022: 0 inspections020222023: 1 inspections120232024: 0 inspections020242025: 0 inspections020252026: 0 inspections02026
YearInspectionsOAIWarning lettersRecall recordsClass I
202600000
202500000
202400000
202310000
202200000
202100000
202010000
201900000
201800000
201710000

Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.

Recent FDA inspections

6 inspections from Aug 14, 2009 to Apr 27, 2023.

DateSiteProductClassificationFEI
Apr 27, 2023Macclesfield, United KingdomDrugsVoluntary Action Indicated (VAI)3002850317
Feb 23, 2020Macclesfield, United KingdomDrugsVoluntary Action Indicated (VAI)3002850317
Apr 13, 2017Macclesfield, United KingdomDrugsNo Action Indicated (NAI)3002850317
Apr 11, 2014Macclesfield, United KingdomDrugsVoluntary Action Indicated (VAI)3002850317
Mar 16, 2012Macclesfield, United KingdomDrugsVoluntary Action Indicated (VAI)3002850317
Aug 14, 2009Macclesfield, United KingdomDrugsVoluntary Action Indicated (VAI)3002850317
NAI
No objectionable conditions or practices were found during the inspection.
VAI
Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
OAI
Regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

FDA-inspected facilities

1 inspected site, newest inspection first.

FacilityLocationInspectionsLatest
FEI 3002850317Macclesfield, United Kingdom6Apr 27, 2023

Need more than this page shows? Ask about AstraZeneca UK Ltd. in Claude or ChatGPT and get every site's inspections, Form 483s, warning letters and import alerts, with a link to the FDA source for each record. The API key is free: no card.

Get a free API key

Prefer a PDF? Request a free supplier snapshot.

FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.