Overview
- 9 public-safe observations are available for this inspection.
- 8 structured CFR citations are represented.
- 5 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
14 Nov 2025
21 CFR 106.10(b)(2)
Personnel - hand washing
Cited by Elizabeth P Mayer, Karen M Labounty, Jake T Lane, Melissa M Schafer, Emily E Markgraf
14 Nov 2025
21 CFR 106.20(a)
Maintain building in clean, sanitary condition
Cited by Elizabeth P Mayer, Karen M Labounty, Jake T Lane, Melissa M Schafer, Emily E Markgraf
14 Nov 2025
21 CFR 106.30(a)
Equipment, utensil - appropriate design
Cited by Elizabeth P Mayer, Karen M Labounty, Jake T Lane, Melissa M Schafer, Emily E Markgraf
14 Nov 2025
21 CFR 106.30(a)
Equipment, utensil - installed to function, clean, maintain
Cited by Elizabeth P Mayer, Karen M Labounty, Jake T Lane, Melissa M Schafer, Emily E Markgraf
14 Nov 2025
21 CFR 106.35(b)(3)
System validated prior to release for distribution
Cited by Elizabeth P Mayer, Karen M Labounty, Jake T Lane, Melissa M Schafer, Emily E Markgraf
Inspected site
MJMead Johnson & Company, LLCWanamingo, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 106.30(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 106.10(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 106.20(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 106.35(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 106.50(d) | 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(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.35(a) | Cited across public-safe Form 483 observations | 1x |
Source document
PDF
PDF available
Form 483 source document
The source document is available to authorized Atlas users.
Full 483 report
Get the verbatim text of all 9 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