Lonza Biologics, Inc.
Form 483 issued November 3, 2020 · Portsmouth, New Hampshire
- Inspection
- Jan 3 – Nov 3, 2020
- Investigator
- Wayne Seifert
- Observations
- 3
- Pages
- 3
- FEI number
- 3001451441
In short: On November 3, 2020, FDA issued a Form 483 with 3 observations to Lonza Biologics, Inc. in Portsmouth, New Hampshire (FEI 3001451441) after an inspection that ran Jan 3 – Nov 3, 2020. The investigator was Wayne Seifert. Most observations concern production and facilities & equipment.
At a glance
2 of 3 observations on this 483 concern production.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
A (b)(4) utility used in manufacture has…
- 02
Manufacturing equipment has not been adequately installed and facilities…
- 03
Standard Operating procedures or work instructions are not…
This inspection in context
Wayne Seifert
37 documents · 2010–2025
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in Germany.
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 3 observations on this Form 483, mostly about production and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Lonza Biologics, Inc.?
Wayne Seifert is named on this Form 483, for the inspection of Jan 3 – Nov 3, 2020. Each investigator has a profile showing what they cite most.
When was Lonza Biologics, Inc. inspected by FDA?
The inspection ran Jan 3 – Nov 3, 2020, and the Form 483 is dated November 3, 2020.
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.