Overview
- 5 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-09-19.
At a glance
Inspections
5
Form 483s
2
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 15 Sep 2025 – 19 Sep 2025 | Foods & Cosmetics | Clean | |
| 16 Sep 2024 – 20 Sep 2024 | Foods & Cosmetics | 483 | View 483 → |
| 28 Aug 2023 – 1 Sep 2023 | Foods & Cosmetics | Clean | |
| 12 Sep 2022 – 16 Sep 2022 | Foods & Cosmetics | 483 | View 483 → |
| 3 Dec 2018 – 4 Dec 2018 | Foods & Cosmetics | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
20 Sep 2024
21 CFR 108.35(c)(2)(ii)
Process change substantiation
Cited by Kibily D Dembele, Kawshalya Pathiraja
20 Sep 2024
21 CFR 113.40(g)(1)(i)(B)(1)
Recorder range, chart graduations
Cited by Kibily D Dembele, Kawshalya Pathiraja
20 Sep 2024
21 CFR 117.130(a)(1)
Hazard analysis - Identification of hazard
Cited by Kibily D Dembele, Kawshalya Pathiraja
20 Sep 2024
21 CFR 117.80(a)
Plant operations - Precautions
Cited by Kibily D Dembele, Kawshalya Pathiraja
16 Sep 2022
21 CFR 113.40(g)(1)(i)(A)
Aseptic processing: TID sensor, display
Cited by Elizabeth P Mayer, Deborah K Richardson, Rene M Amaguana
Investigators
FDA investigators tied to this site in the record.
Danny Tuntevski1 insp.
Stephen G Mclane1 insp.
Kibily D Dembele1 insp.
Kawshalya Pathiraja1 insp.
Gale L Glinecki1 insp.
Elizabeth P Mayer1 insp.
Deborah K Richardson1 insp.
Rene M Amaguana1 insp.
Dhaval H Patel1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 113.40(g)(1)(i)(B)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 108.35(c)(2)(ii) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 113.40(g)(1)(i)(A) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 113.40(g)(2)(ii)(C) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.10 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.130(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.35(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.80(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.80(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.80(c) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Nutricia NV's 2 Form 483s
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