FDA Form 483 GSK Vaccines GmbH, Marburg, Germany Feb 2024
Form 483 issued March 6, 2024 · Marburg, Germany
- Inspection
- Feb 26 – Mar 6, 2024
- Investigators
- Tha I. D. Truong· Thai D. Truong· Unnee Ra Njan
- Observations
- 4
- Pages
- 5
In short: On March 6, 2024, FDA issued a Form 483 with 4 observations to FDA Form 483 GSK Vaccines GmbH, Marburg, Germany Feb 2024 in Marburg, Hassia after an inspection that ran Feb 26 – Mar 6, 2024. The investigators were Tha I. D. Truong, Thai D. Truong, Unnee Ra Njan and Unnee Ranjan. Most observations concern production and quality system.
At a glance
Observations span 4 systems, led by production.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 02
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 03
Separate or defined areas to…
- 04
Documents and (6)(4) drug…
This inspection in context
Tha I. D. Truong
1 document · 2024
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Germany.
The firmFDA Form 483 GSK Vaccines GmbH, Marburg, Germany Feb 2024 history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at FDA Form 483 GSK Vaccines GmbH, Marburg, Germany Feb 2024?
FDA listed 4 observations on this Form 483, mostly about production, quality system and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected FDA Form 483 GSK Vaccines GmbH, Marburg, Germany Feb 2024?
Tha I. D. Truong, Thai D. Truong, Unnee Ra Njan and Unnee Ranjan are named on this Form 483, for the inspection of Feb 26 – Mar 6, 2024. Each investigator has a profile showing what they cite most.
When was FDA Form 483 GSK Vaccines GmbH, Marburg, Germany Feb 2024 inspected by FDA?
The inspection ran Feb 26 – Mar 6, 2024, and the Form 483 is dated March 6, 2024.
How do I get the full Form 483 for FDA Form 483 GSK Vaccines GmbH, Marburg, Germany Feb 2024?
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.