Overview
- 2 public-safe observations are available for this inspection.
- 2 structured CFR citations are represented.
- 7 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
4 Dec 2017
21 CFR 106.30(b)
Equipment, utensil - design: cleanable, intended use
Cited by Elizabeth P Mayer, Erin M Miller, Danny Tuntevski, Daniel B Arrecis, Jayne E Holcomb, Julia A Avery, Christi L Bellmore
4 Dec 2017
21 CFR 106.55(a)
System of process controls to prevent adulteration
Cited by Elizabeth P Mayer, Erin M Miller, Danny Tuntevski, Daniel B Arrecis, Jayne E Holcomb, Julia A Avery, Christi L Bellmore
Inspected site
MJMead Johnson & Company, LLCZeeland, United States
Inspection team
EMErin M Miller
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 106.30(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 106.55(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 2 observations
The source PDF and every observation in full, 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