Lonza Biologics, Inc.
Form 483 issued April 16, 2026 · Portsmouth, New Hampshire
- Inspection
- Apr 8 – Apr 16, 2026
- Investigators
- Christian Lynch· Laurel A. Beer
- Observations
- 2
- Pages
- 5
- FEI number
- 3001451441
In short: On April 16, 2026, FDA issued a Form 483 with 2 observations to Lonza Biologics, Inc. in Portsmouth, New Hampshire (FEI 3001451441) after an inspection that ran Apr 8 – Apr 16, 2026. The investigators were Christian Lynch and Laurel A. Beer. Most observations concern production; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 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
Your firm failed to establish written procedures for production and process controls designed to assure that…
This inspection in context
Christian Lynch
4 documents · 2016–2026
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in New Hampshire.
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 211.100
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 production. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Lonza Biologics, Inc.?
Christian Lynch and Laurel A. Beer are named on this Form 483, for the inspection of Apr 8 – Apr 16, 2026. Each investigator has a profile showing what they cite most.
When was Lonza Biologics, Inc. inspected by FDA?
The inspection ran Apr 8 – Apr 16, 2026, and the Form 483 is dated April 16, 2026.
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.