Overview
- 5 public-safe observations are available for this inspection.
- 5 structured CFR citations are represented.
- 3 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
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
26 May 2023
21 CFR 106.6(c)(2)
Monitor production, in-process control point
Cited by Elizabeth P Mayer, Tressa T Lewis, Megan E Kerry
26 May 2023
21 CFR 106.91(a)(1)
Production aggregate - test each nutrient, added or premix
Cited by Elizabeth P Mayer, Tressa T Lewis, Megan E Kerry
26 May 2023
21 CFR 117.80(c)
Manufacturing, processing, packing, holding - Controls
Cited by Elizabeth P Mayer, Tressa T Lewis, Megan E Kerry
Inspected site
MGMilupa GmbHFulda, Germany
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 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 106.6(c)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 106.91(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.80(c) | Cited across public-safe Form 483 observations | 1x |
Source document
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PDF available
Form 483 source document
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Full 483 report
Get the verbatim text of all 5 observations
The source PDF, so your team sees exactly what was cited and how it was answered.
- The site's full inspection history around this Form 483
- Whether these citations escalated to a warning letter
- The investigators involved and the citations they repeat elsewhere