MedImmune UK, Ltd.
Form 483 issued March 15, 2024 · Liverpool, United Kingdom
- Inspection
- Mar 7 – Mar 15, 2024
- Investigators
- Anissa M. Cheung· Brentley Collins· Gene D. Arcy
- Observations
- 4
- Pages
- 4
- FEI number
- 3004066112
In short: On March 15, 2024, FDA issued a Form 483 with 4 observations to MedImmune UK, Ltd. in Liverpool, United Kingdom (FEI 3004066112) after an inspection that ran Mar 7 – Mar 15, 2024. The investigators were Anissa M. Cheung, Brentley Collins and Gene D. Arcy. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and laboratory controls account for 3 of 4 observations.
Most cited: 21 CFR 211.192 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Inadequate information and impact assessment were…
- 02
Observation 2: scanned text, readable in the full document.
- 03
Observation 3: scanned text, readable in the full document.
- 04
Your firm’s batch record is not designed to capture critical information in support of which are…
This inspection in context
Anissa M. Cheung
7 documents · 2017–2024
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Massachusetts.
The firmMedImmune UK, Ltd. history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at MedImmune UK, Ltd.?
FDA listed 4 observations on this Form 483, mostly about quality system, laboratory controls and production. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected MedImmune UK, Ltd.?
Anissa M. Cheung, Brentley Collins and Gene D. Arcy are named on this Form 483, for the inspection of Mar 7 – Mar 15, 2024. Each investigator has a profile showing what they cite most.
When was MedImmune UK, Ltd. inspected by FDA?
The inspection ran Mar 7 – Mar 15, 2024, and the Form 483 is dated March 15, 2024.
How do I get the full Form 483 for MedImmune UK, Ltd.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.