Overview
- 16 FDA inspections are on record.
- 8 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-03-24.
At a glance
Inspections
16
Form 483s
8
EIRs
1
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 18 Mar 2026 – 24 Mar 2026 | Medical Devices & Rad Health | Clean | |
| 1 Nov 2021 – 5 Nov 2021 | Biologics | 483 | View 483 → |
| 16 Jul 2018 – 26 Jul 2018 | Biologics | 483 | On file |
| 25 Jun 2018 – 3 Jul 2018 | Medical Devices & Rad Health | 483 | View 483 → |
| 18 Jan 2017 – 6 Feb 2017 | Medical Devices & Rad Health | WL | View 483 → |
| 6 Jun 2016 – 9 Jun 2016 | Biologics | 483 | On file |
| 7 Aug 2013 – 13 Aug 2013 | Biologics | 483 | On file |
| 2 Dec 2011 | Not recorded | 483 | View 483 → |
| 23 Aug 2011 | Not recorded | Clean | |
| 17 Dec 2009 | Not recorded | Clean | |
| 10 Oct 2008 | Not recorded | 483 | View 483 → |
| 13 Sep 2007 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
5 Nov 2021
21 CFR 820.198(a)
Lack of or inadequate complaint procedures
Cited by Eileen A Liu, Jude C Dike
5 Nov 2021
21 CFR 820.70(e)
Contamination control, Lack of or inadequate procedures
Cited by Eileen A Liu, Jude C Dike
5 Nov 2021
21 CFR 820.75(a)
Lack of or inadequate process validation
Cited by Eileen A Liu, Jude C Dike
5 Nov 2021
21 CFR 820.75(b)
Lack/Inad procedure-Monitoring/Control of Validated Proces
Cited by Eileen A Liu, Jude C Dike
Investigators
FDA investigators tied to this site in the record.
James M Simpson2 insp.
Christina D Mello1 insp.
Andrea D Gomez1 insp.
Eileen A Liu1 insp.
Jude C Dike1 insp.
Gene D Arcy1 insp.
James L Kenney1 insp.
Hyesuk Kong1 insp.
Steven P Donald1 insp.
Marc S Neubauer1 insp.
Burnell M Henry1 insp.
Christian Lynch1 insp.
Susan M Jackson1 insp.
Helen B Ricalde1 insp.
Patricia A Morrow1 insp.
James T Mccoy1 insp.
Ann M Montemurro1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.70(a) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.70(c) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.75(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 600.14(a)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.100(a)(3) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.72(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 601.12(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 807.21(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.140 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.150(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.184 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.20(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.25(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.40 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(b)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Lonza Walkersville, Inc.'s 8 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