FDA Form 483 Lonza Portsmouth, NH June 2025
Form 483 issued June 6, 2025
- Inspection
- Jun 2 – Jun 6, 2025
- Investigator
- This Page
- Observations
- 10
- Pages
- 8
In short: On June 6, 2025, FDA issued a Form 483 with 10 observations to FDA Form 483 Lonza Portsmouth, NH June 2025 after an inspection that ran Jun 2 – Jun 6, 2025. The investigator was This Page. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and facilities & equipment account for 8 of 10 observations.
Most cited: 21 CFR 211.113 (4×) · 211.56 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Aseptic processing of CASGEVY…
- 02
Cleaning of Grade areas used in the manufacture of CASGEVY…
- 03
The following practices that are inconsistent with Good…
- 04
Heating, ventilation, and air conditioning maintenance…
This inspection in context
This Page
2 documents · 2025–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Ohio.
The firmFDA Form 483 Lonza Portsmouth, NH June 2025 history
The site's inspection history, in date order.
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 FDA Form 483 Lonza Portsmouth, NH June 2025?
FDA listed 10 observations on this Form 483, mostly about production, facilities & equipment and quality system. 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 FDA Form 483 Lonza Portsmouth, NH June 2025?
This Page is named on this Form 483, for the inspection of Jun 2 – Jun 6, 2025. Each investigator has a profile showing what they cite most.
When was FDA Form 483 Lonza Portsmouth, NH June 2025 inspected by FDA?
The inspection ran Jun 2 – Jun 6, 2025, and the Form 483 is dated June 6, 2025.
How do I get the full Form 483 for FDA Form 483 Lonza Portsmouth, NH June 2025?
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.