Overview
- 21 FDA inspections are on record.
- 7 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-07-30.
At a glance
Inspections
21
Form 483s
7
EIRs
6
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 14 Jul 2025 – 30 Jul 2025 | Biologics | 483 | View 483 → |
| 30 May 2023 – 2 Jun 2023 | Human Drugs | 483 | View 483 → |
| 6 Sep 2022 – 13 Sep 2022 | Medical Devices & Rad Health | Clean | |
| 3 Nov 2021 – 9 Nov 2021 | Biologics | Clean | |
| 27 Mar 2018 – 30 Mar 2018 | Human Drugs | Clean | |
| 21 Feb 2018 – 23 Feb 2018 | Biologics | Clean | |
| 12 Apr 2016 – 15 Apr 2016 | Biologics | 483 | On file |
| 22 Feb 2016 – 26 Feb 2016 | Medical Devices & Rad Health | 483 | View 483 → |
| 22 Jun 2015 – 25 Jun 2015 | Medical Devices & Rad Health | Clean | |
| 15 Jul 2014 – 25 Jul 2014 | Human Drugs | Clean | |
| 14 Jul 2014 – 25 Jul 2014 | Medical Devices & Rad Health | Clean | |
| 6 Jan 2014 – 10 Jan 2014 | Human Drugs | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
30 Jul 2025
21 CFR 1271.180(a)
Design adequate to bar spread of CD's
Cited by Laurissa S Flowers, Emily B Camire
30 Jul 2025
21 CFR 1271.195(a)
Adequate control, proper conditions
Cited by Laurissa S Flowers, Emily B Camire
30 Jul 2025
21 CFR 1271.220(a)
Causing contamination, increasing risks
Cited by Laurissa S Flowers, Emily B Camire
Investigators
FDA investigators tied to this site in the record.
Marc A Jackson3 insp.
Matthew R Dionne2 insp.
Steven C Madzo2 insp.
Laurissa S Flowers1 insp.
Emily B Camire1 insp.
Bryan A Galvez1 insp.
Theressa B Smith1 insp.
Lewis K Antwi1 insp.
Jacqueline M Diaz Albert1 insp.
Jacqueline M Diaz Albertini1 insp.
Marijo B Kambere1 insp.
Santiago Gallardo Johnson1 insp.
Susan M Jackson1 insp.
Mihaly S Ligmond1 insp.
Jamie L Dion1 insp.
Marie B Buen-Bigornia1 insp.
Daniel J Lahar1 insp.
Kimberley A Hoefen1 insp.
Hanna L Potter1 insp.
James R Montero1 insp.
Jessie E Morris1 insp.
Michael R Goga1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 1271.160(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.160(b)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.180(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.195(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.220(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.220(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.270(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(9) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(c) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Nelson Laboratories, LLC's 7 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