MedImmune UK, Ltd.
Form 483 issued June 8, 2018 · Liverpool, United Kingdom
- Inspection
- May 29 – Jun 8, 2018
- Investigator
- Omotunde O. Osunsanmi
- Observations
- 6
- Pages
- 4
- FEI number
- 3004066112
In short: On June 8, 2018, FDA issued a Form 483 with 6 observations to MedImmune UK, Ltd. in Liverpool, United Kingdom (FEI 3004066112) after an inspection that ran May 29 – Jun 8, 2018. The investigator was Omotunde O. Osunsanmi. Most observations concern production and materials; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Production and materials account for 4 of 6 observations.
Most cited: 21 CFR 211.100 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Observation 1: scanned text, readable in the full document.
- 02
SOP 100296 Version 7.0, titled: Deviation Procedure that includes procedure for corrective and preventive actions (CAPA)…
- 03
During the observation of the sterility testing of…
- 04
Critical] © and equipment alarms that occurred during the manufacture of 4) are not trended for…
This inspection in context
Omotunde O. Osunsanmi
13 documents · 2003–2020
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in United Kingdom.
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 211.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at MedImmune UK, Ltd.?
FDA listed 6 observations on this Form 483, mostly about production, materials and laboratory controls. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected MedImmune UK, Ltd.?
Omotunde O. Osunsanmi is named on this Form 483, for the inspection of May 29 – Jun 8, 2018. Each investigator has a profile showing what they cite most.
When was MedImmune UK, Ltd. inspected by FDA?
The inspection ran May 29 – Jun 8, 2018, and the Form 483 is dated June 8, 2018.
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.