Lonza Biologics, Inc.
Form 483 issued March 7, 2024 · Portsmouth, New Hampshire
- Inspection
- Mar 7, 2024
- Investigators
- Lewis K. Antwi· Priscilla M. Pastrana· Svetlana A. Shestopal
- Observations
- 2
- Pages
- 4
- FEI number
- 3001451441
In short: On March 7, 2024, FDA issued a Form 483 with 2 observations to Lonza Biologics, Inc. in Portsmouth, New Hampshire (FEI 3001451441) after an inspection that ran Mar 7, 2024. The investigators were Lewis K. Antwi, Priscilla M. Pastrana, Svetlana A. Shestopal and Vijaya Simhadri. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and production account for 2 of 2 observations.
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
Failure to conduct investigations…
- 02
Failure to follow established…
This inspection in context
Lewis K. Antwi
11 documents · 2019–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmLonza Biologics, Inc. history
All 7 documents on file for this site, in date order, with what was cited at each inspection.
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 Lonza Biologics, Inc.?
FDA listed 2 observations on this Form 483, mostly about quality system and production. 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 Lonza Biologics, Inc.?
Lewis K. Antwi, Priscilla M. Pastrana, Svetlana A. Shestopal and Vijaya Simhadri are named on this Form 483, for the inspection of Mar 7, 2024. Each investigator has a profile showing what they cite most.
When was Lonza Biologics, Inc. inspected by FDA?
The inspection ran Mar 7, 2024, and the Form 483 is dated March 7, 2024.
How do I get the full Form 483 for Lonza Biologics, Inc.?
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.