In short: On April 4, 2025, FDA issued a Form 483 with 1 observation to Lonza AG (FEI 3012793444). The investigator was Melissa Ray.
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
This inspection in context
Melissa Ray
3 documents · 2022–2025
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Lithuania.
The firmLonza AG history
The site's inspection history, in date order.
Similar 483sMore form 483s
Browse other documents of this type.
Questions about this 483
What did FDA find at Lonza AG?
FDA listed 1 observation on this Form 483. The opening words of each observation are shown on this page.
Who inspected Lonza AG?
Melissa Ray is named on this Form 483. Each investigator has a profile showing what they cite most.
When was Lonza AG inspected by FDA?
This Form 483 is dated April 4, 2025.
How do I get the full Form 483 for Lonza 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.