Overview
- 18 FDA inspections are on record.
- 7 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-05-09.
At a glance
Inspections
18
Form 483s
7
EIRs
3
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 5 May 2025 – 9 May 2025 | Foods & Cosmetics | 483 | View 483 → |
| 3 Jun 2024 – 7 Jun 2024 | Foods & Cosmetics | 483 | View 483 → |
| 22 May 2023 – 26 May 2023 | Foods & Cosmetics | 483 | View 483 → |
| 3 May 2022 – 7 May 2022 | Foods & Cosmetics | 483 | View 483 → |
| 23 Sep 2019 – 27 Sep 2019 | Foods & Cosmetics | Clean | |
| 17 Sep 2018 – 18 Sep 2018 | Foods & Cosmetics | Clean | |
| 4 Sep 2017 – 7 Sep 2017 | Foods & Cosmetics | Clean | |
| 19 Sep 2016 – 22 Sep 2016 | Foods & Cosmetics | 483 | On file |
| 14 Sep 2015 – 17 Sep 2015 | Foods & Cosmetics | 483 | View 483 → |
| 15 Sep 2014 | Foods & Cosmetics | Clean | |
| 23 Sep 2013 – 25 Sep 2013 | Foods & Cosmetics | Clean | |
| 27 Jun 2012 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
9 May 2025
21 CFR 106.55(a)
System of process controls to prevent adulteration
Cited by Amy L Mcintyre, Stephen G Mclane
7 Jun 2024
21 CFR 106.91(a)(1)
Production aggregate - test each nutrient, added or premix
Cited by Danny Tuntevski, Gale L Glinecki
7 Jun 2024
21 CFR 106.91(a)(1)
Production aggregate - test each nutrient, added or premix
Cited by Danny Tuntevski, Gale L Glinecki
26 May 2023
21 CFR 106.30(d)
Instrument used to measure, regulate, control parameter
Cited by Elizabeth P Mayer, Tressa T Lewis, Megan E Kerry
26 May 2023
21 CFR 106.30(e)(2)(ii)
Cold storage, in-process and final formula - 45 degrees F
Cited by Elizabeth P Mayer, Tressa T Lewis, Megan E Kerry
Investigators
FDA investigators tied to this site in the record.
Elizabeth P Mayer3 insp.
Eric Rothschild2 insp.
Amy L Mcintyre1 insp.
Stephen G Mclane1 insp.
Danny Tuntevski1 insp.
Gale L Glinecki1 insp.
Tressa T Lewis1 insp.
Megan E Kerry1 insp.
Jane Chen1 insp.
Karen M Labounty1 insp.
Brian Ravitch1 insp.
Pedro A Cruz1 insp.
Rene M Amaguana1 insp.
Megan E Kulas1 insp.
Sonia D Hudson1 insp.
Brian R Yaun1 insp.
Cary Greene1 insp.
Kathleen J Close1 insp.
Andrew F Cohen1 insp.
Annemarie Kleiza1 insp.
Edward Oshaughnessy1 insp.
Nianna C Burns1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 117.80(c) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 106.91(a)(1) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 106.30(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 106.30(e)(2)(ii) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 106.55(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 106.6(c)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.40(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.80 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.80(a)(1) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Milupa GmbH'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