Lonza Biologics, Inc.
FDA inspection history in Portsmouth, New Hampshire, 2020 to 2026
- 7
- Form 483s
Every document, by year
- Form 483
2020: one Form 483; 2021: one Form 483; 2023: one Form 483; 2024: two Form 483s; 2025: one Form 483; 2026: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2020–26Seven Form 483s, at Portsmouth, New Hampshire.
- 2025The longest 483 on file: 10 observations over 8 pages at Portsmouth, New Hampshire.
Cited most
Across all Lonza Biologics observations on file
- 21 CFR 211.100Written procedures; deviations4
- 21 CFR 211.192Production record review3
- 21 CFR 211.113Control of microbiological contamination2
- 21 CFR 211.56Sanitation2
- 21 CFR 211.58Maintenance2
The complete Lonza Biologics file.
All 7 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
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Sites
Portsmouth, New Hampshire
Seven Form 483s · 2020 to 2026 · 20 observations
Latest: Form 483, Apr 16, 2026 →
Documents
7 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2026-04-16 | 483 Form 483 | Portsmouth, New Hampshire | 2 | $99 |
| 2025-06-06 | 483 Form 483 | Portsmouth, New Hampshire | 10 | $99 |
| 2024-07-12 | 483 Form 483 | Portsmouth, New Hampshire | 3 | $99 |
| 2024-03-07 | 483 Form 483 | Portsmouth, New Hampshire | — | $99 |
| 2023-07-21 | 483 Form 483 | Portsmouth, New Hampshire | 1 | $99 |
| 2021-10-22 | 483 Form 483 | Portsmouth, New Hampshire | 4 | $99 |
| 2020-11-03 | 483 Form 483 | Portsmouth, New Hampshire | — | $99 |
Investigators on these documents
Christian Lynch (1)Debra M. Emerson (1)Kinjal Patel (1)Laurel A. Beer (1)Lewis K. Antwi (1)Massoud Motamed (1)Meng Rowland (1)Obinna Echeozo (1)Priscilla M. Pastrana (1)Robert J. Maxwell (1)Svetlana A. Shestopal (1)Timothy Kamaldinov (1)
FEI number 3001451441 · most recent document Apr 16, 2026
About Lonza Biologics, Inc.
How many FDA Form 483s has Lonza Biologics, Inc. received?
FDA Intel has 7 Form 483s on file for Lonza Biologics, Inc.; the most recent is dated Apr 16, 2026.
When was Lonza Biologics, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Lonza Biologics, Inc. is a Form 483 dated Apr 16, 2026, for the site in Portsmouth, New Hampshire.
What did FDA cite at Lonza Biologics, Inc.?
The regulations cited most in the observations on file for Lonza Biologics, Inc. are 21 CFR 211.100 (Written procedures; deviations), 4 times; 21 CFR 211.192 (Production record review), 3 times; 21 CFR 211.113 (Control of microbiological contamination), 2 times.