Cilag AG
Form 483 issued September 23, 2024 · Schaffhausen, Switzerland
- Inspection
- Sep 17 – Sep 23, 2024
- Investigators
- Hyung-Yul Lee· Thuy T. Nguyen
- Observations
- 4
- Pages
- 3
- FEI number
- 3002806695
In short: On September 23, 2024, FDA issued a Form 483 with 4 observations to Cilag AG in Schaffhausen, Switzerland (FEI 3002806695) after an inspection that ran Sep 17 – Sep 23, 2024. The investigators were Hyung-Yul Lee and Thuy T. Nguyen. Most observations concern facilities & equipment and production.
At a glance
Facilities & equipment and production account for 3 of 4 observations.
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 not…
- 02
Aseptic processing areas are inadequate regarding the system…
- 03
Your examination and testing of samples did not assure that the drug product and in-process…
- 04
Facilities and equipment used during the manufacturing of| Po drug product…
This inspection in context
Hyung-Yul Lee
5 documents · 2023–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Indiana.
The firmCilag AG history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
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 Cilag AG?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment and production. The opening words of each observation are shown on this page.
Who inspected Cilag AG?
Hyung-Yul Lee and Thuy T. Nguyen are named on this Form 483, for the inspection of Sep 17 – Sep 23, 2024. Each investigator has a profile showing what they cite most.
When was Cilag AG inspected by FDA?
The inspection ran Sep 17 – Sep 23, 2024, and the Form 483 is dated September 23, 2024.
How do I get the full Form 483 for Cilag AG?
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.