Lonza Biologics, Inc.
Form 483 issued July 12, 2024 · Portsmouth, New Hampshire
- Investigator
- Meng Rowland
- Observations
- 3
- Pages
- 1
- FEI number
- 3001451441
In short: On July 12, 2024, FDA issued a Form 483 with 3 observations to Lonza Biologics, Inc. in Portsmouth, New Hampshire (FEI 3001451441). The investigator was Meng Rowland. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and facilities & equipment account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your investigations for invalid assays are inadequate, and actions taken do not prevent recurrence of the…
- 02
Equipment maintenance is deficient in its ability…
- 03
Your firm’s Quality Control laboratory ambient (room) temperature storage areas…
This inspection in context
Meng Rowland
1 document · 2024
Cites 211.160 (general requirements) 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 211.192
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 quality system, facilities & equipment and laboratory controls. 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.?
Meng Rowland is named on this Form 483. Each investigator has a profile showing what they cite most.
When was Lonza Biologics, Inc. inspected by FDA?
This Form 483 is dated July 12, 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.