Overview
- 24 FDA inspections are on record.
- 16 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-04-16.
At a glance
Inspections
24
Form 483s
16
EIRs
4
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 8 Apr 2026 – 16 Apr 2026 | Biologics | 483 | View 483 → |
| 28 Jan 2026 – 6 Feb 2026 | Human Drugs | 483 | On file |
| 2 Jun 2025 – 6 Jun 2025 | Biologics | 483 | On file |
| 8 Jul 2024 – 12 Jul 2024 | Human Drugs | 483 | On file |
| 28 Feb 2024 – 7 Mar 2024 | Biologics | 483 | On file |
| 6 Jul 2023 – 21 Jul 2023 | Human Drugs | 483 | On file |
| 18 Oct 2021 – 22 Oct 2021 | Biologics | 483 | On file |
| 28 Oct 2020 – 3 Nov 2020 | Human Drugs | 483 | On file |
| 5 Feb 2018 – 7 Feb 2018 | Human Drugs | Clean | |
| 5 Sep 2017 – 21 Sep 2017 | Human Drugs | Clean | |
| 9 Aug 2016 – 26 Aug 2016 | Human Drugs | 483 | On file |
| 2 May 2016 – 6 May 2016 | Human Drugs | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
16 Apr 2026
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Christian Lynch, Laurel A Beer
16 Apr 2026
21 CFR 211.142
Written warehousing procedures established/followed
Cited by Christian Lynch, Laurel A Beer
Investigators
FDA investigators tied to this site in the record.
Debra M Emerson4 insp.
Sean R Marcsisin2 insp.
Robert J Martin2 insp.
Stacey S Degarmo2 insp.
Christian Lynch1 insp.
Laurel A Beer1 insp.
Emmanuel T Donyina1 insp.
Massoud Motamed1 insp.
Xiuju Lu1 insp.
Timothy Kamaldinov1 insp.
Kinjal S Patel1 insp.
Athena L Russell1 insp.
Michael Shanks1 insp.
Yi Wang1 insp.
Lewis K Antwi1 insp.
Priscilla M Pastrana1 insp.
Vijaya L Simhadri1 insp.
Svetlana A Shestopal1 insp.
Pankaj H Amin1 insp.
Obinna R Echeozo1 insp.
Wayne E Seifert1 insp.
Scott R Nichols1 insp.
Patricia F Hughes Troost1 insp.
Bo Chi1 insp.
Robert C Horan1 insp.
Donald C Obenhuber1 insp.
Candace Y Gomez-Broughton1 insp.
Mary-Jeanet Mcgarry1 insp.
Ramon E Martinez1 insp.
Kalavati C Suvarna1 insp.
Michelle Y Clark Stuart1 insp.
Megan A Haggerty1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.113(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.142 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Lonza Biologics, Inc.'s 16 Form 483s
Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat