MedImmune UK, Ltd.
Amended 483 issued March 29, 2007 · Speke, Liverpool, United Kingdom
- Inspection
- Mar 21 – Mar 29, 2007
- Investigators
- Mihaly S. Ligmond· Omotunde O. Osunsanmi· Steven A. Rubin
- Observations
- 14
- Pages
- 8
- FEI number
- 3004066112
In short: On March 29, 2007, FDA issued a Amended 483 with 14 observations to MedImmune UK, Ltd. in Speke, Liverpool, United Kingdom (FEI 3004066112) after an inspection that ran Mar 21 – Mar 29, 2007. The investigators were Mihaly S. Ligmond, Omotunde O. Osunsanmi and Steven A. Rubin. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Observations span 4 systems, led by production.
Most cited: 21 CFR 211.113 (4×) · 211.67 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Regarding control over product…
- 02
Regarding investigations conducted into the above microbial action levels of monovalent lots with high bioburden levels…
- 03
The following were observed during the set-up, sterile filtration, and/or aseptic dispensing of A/Wisconsin Monovalent Batch…
- 04
Regarding disinfectant effectiveness…
10 more observations
Plus the full detail behind each one, exactly as FDA wrote it.
Get the full amended 483This inspection in context
Mihaly S. Ligmond
20 documents · 2006–2024
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Ireland.
The firmMedImmune UK, Ltd. history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar documentsOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this amended 483
What did FDA find at MedImmune UK, Ltd.?
FDA listed 14 observations on this Form 483, mostly about production, facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected MedImmune UK, Ltd.?
Mihaly S. Ligmond, Omotunde O. Osunsanmi and Steven A. Rubin are named on this Amended 483, for the inspection of Mar 21 – Mar 29, 2007. Each investigator has a profile showing what they cite most.
When was MedImmune UK, Ltd. inspected by FDA?
The inspection ran Mar 21 – Mar 29, 2007, and the Amended 483 is dated March 29, 2007.
How do I get the full Amended 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.