FDA Form 483 Lonza Netherlands BV, Geleen, Netherlands, July 2024
Form 483 issued July 12, 2024
- Inspection
- Jul 8 – Jul 12, 2024
- Investigators
- Carl Perez· Graeme Price· Jie He
- Observations
- 2
- Pages
- 2
- FEI number
- 3014382532
In short: On July 12, 2024, FDA issued a Form 483 with 2 observations to FDA Form 483 Lonza Netherlands BV, Geleen, Netherlands, July 2024 (FEI 3014382532) after an inspection that ran Jul 8 – Jul 12, 2024. The investigators were Carl Perez, Graeme Price, Jie He and Timothy Kamaldinov. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Observations span 1 system, led by quality system.
Most cited: 21 CFR 211.192 (1×) · 211.100 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Inadequate procedures to document decisions following an out-of-specification…
- 02
The process (equipment and procedures for the storage and shipment of commercial drug product (DP)…
This inspection in context
Carl Perez
7 documents · 2022–2025
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in California.
The firmFDA Form 483 Lonza Netherlands BV, Geleen, Netherlands, July 2024 history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at FDA Form 483 Lonza Netherlands BV, Geleen, Netherlands, July 2024?
FDA listed 2 observations on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected FDA Form 483 Lonza Netherlands BV, Geleen, Netherlands, July 2024?
Carl Perez, Graeme Price, Jie He and Timothy Kamaldinov are named on this Form 483, for the inspection of Jul 8 – Jul 12, 2024. Each investigator has a profile showing what they cite most.
When was FDA Form 483 Lonza Netherlands BV, Geleen, Netherlands, July 2024 inspected by FDA?
The inspection ran Jul 8 – Jul 12, 2024, and the Form 483 is dated July 12, 2024.
How do I get the full Form 483 for FDA Form 483 Lonza Netherlands BV, Geleen, Netherlands, July 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.