Overview
- 6 public-safe observations are available for this inspection.
- 3 structured CFR citations are represented.
- 2 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
26 Aug 2021
21 CFR 113.100(a)
Critical factors - no record
Cited by Elizabeth P Mayer, Daniel B Arrecis
26 Aug 2021
21 CFR 113.100(a)
Critical factors - no record
Cited by Elizabeth P Mayer, Daniel B Arrecis
26 Aug 2021
21 CFR 113.40(c)(1)(v)
TID not accurately, easily read
Cited by Elizabeth P Mayer, Daniel B Arrecis
26 Aug 2021
21 CFR 113.40(c)(1)(v)
TID not accurately, easily read
Cited by Elizabeth P Mayer, Daniel B Arrecis
26 Aug 2021
21 CFR 113.40(g)(2)(ii)(C)
Operating conditions observed, recorded - frequency
Cited by Elizabeth P Mayer, Daniel B Arrecis
Inspected site
MJMead Johnson & Company, LLCEvansville, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 113.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 113.40(c)(1)(v) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 113.40(g)(2)(ii)(C) | Cited across public-safe Form 483 observations | 2x |
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 6 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