MedImmune UK, Ltd.
FDA inspection history across 2 sites, 2007 to 2024
- 3
- Form 483s
Every document, by year
- Form 483
2007: one amended 483; 2018: one Form 483; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2007One amended 483, at Speke, Liverpool, United Kingdom.
- 2007The longest 483 on file: 11 observations over 8 pages at Speke, Liverpool, United Kingdom.
- 2018One Form 483, at Liverpool, United Kingdom.
- 2024One Form 483, at Liverpool, United Kingdom.
Cited most
Across all MedImmune UK observations on file
- 21 CFR 211.113Control of microbiological contamination5
- 21 CFR 211.192Production record review4
- 21 CFR 211.160General requirements3
- 21 CFR 211.67Equipment cleaning and maintenance3
- 21 CFR 211.100Written procedures; deviations2
The complete MedImmune UK file.
All 3 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Liverpool, United Kingdom
Two Form 483s · 2018 to 2024 · 10 observations
Latest: Form 483, Mar 15, 2024 →Speke, Liverpool, United Kingdom
One amended 483 · 2007 · 11 observations
Latest: Form 483, Mar 29, 2007 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-03-15 | 483 Form 483 | Liverpool, United Kingdom | 4 | $99 |
| 2018-06-08 | 483 Form 483 | Liverpool, United Kingdom | 6 | $99 |
| 2007-03-29 | Amended 483 Amended 483 | Speke, Liverpool, United Kingdom | 11 | $99 |
Investigators on these documents
Omotunde O. Osunsanmi (2)Anissa M. Cheung (1)Brentley Collins (1)Gene D. Arcy (1)Mihaly S. Ligmond (1)Steven A. Rubin (1)
FEI number 3004066112 · most recent document Mar 15, 2024
About MedImmune UK, Ltd.
How many FDA Form 483s has MedImmune UK, Ltd. received?
FDA Intel has 3 Form 483s on file for MedImmune UK, Ltd.; the most recent is dated Mar 15, 2024.
When was MedImmune UK, Ltd. last inspected by FDA?
The most recent FDA inspection document on file for MedImmune UK, Ltd. is a Form 483 dated Mar 15, 2024, for the site in Liverpool, United Kingdom.
What did FDA cite at MedImmune UK, Ltd.?
The regulations cited most in the observations on file for MedImmune UK, Ltd. are 21 CFR 211.113 (Control of microbiological contamination), 5 times; 21 CFR 211.192 (Production record review), 4 times; 21 CFR 211.160 (General requirements), 3 times.