Lonza Biologics, Inc.
Form 483 issued July 21, 2023 · Portsmouth, New Hampshire
- Inspection
- Jul 7 – Jul 21, 2023
- Investigator
- Robert J. Maxwell
- Observations
- 1
- Pages
- 2
- FEI number
- 3001451441
In short: On July 21, 2023, FDA issued a Form 483 with 1 observation to Lonza Biologics, Inc. in Portsmouth, New Hampshire (FEI 3001451441) after an inspection that ran Jul 7 – Jul 21, 2023. The investigator was Robert J. Maxwell. Most observations concern production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Observation 1: scanned text, readable in the full document.
This inspection in context
Robert J. Maxwell
1 document · 2023
Cites 211.113 (control of microbiological contamination) 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 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Lonza Biologics, Inc.?
FDA listed 1 observation on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Lonza Biologics, Inc.?
Robert J. Maxwell is named on this Form 483, for the inspection of Jul 7 – Jul 21, 2023. Each investigator has a profile showing what they cite most.
When was Lonza Biologics, Inc. inspected by FDA?
The inspection ran Jul 7 – Jul 21, 2023, and the Form 483 is dated July 21, 2023.
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.