Overview
- 11 public-safe observations are available for this inspection.
- 10 structured CFR citations are represented.
- 4 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
4 Nov 2016
21 CFR 110.10(d)
Supervision
Cited by Lourdes Andujar, Peter T Erlandson, Thomas J Arista, Joel D Hustedt
4 Nov 2016
21 CFR 110.20(b)(2)
Contamination with microorganisms, chemicals, filth, etc.
Cited by Lourdes Andujar, Peter T Erlandson, Thomas J Arista, Joel D Hustedt
4 Nov 2016
21 CFR 110.35(a)
Buildings/good repair
Cited by Lourdes Andujar, Peter T Erlandson, Thomas J Arista, Joel D Hustedt
4 Nov 2016
21 CFR 110.35(d)(5)
Shown to be effective
Cited by Lourdes Andujar, Peter T Erlandson, Thomas J Arista, Joel D Hustedt
4 Nov 2016
21 CFR 110.40(f)
Q.C. instrument accuracy, maintenance
Cited by Lourdes Andujar, Peter T Erlandson, Thomas J Arista, Joel D Hustedt
Inspected site
MIMane Ingredients USA, IncMenomonee Falls, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 110.80 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 110.10(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.20(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.35(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.35(d)(5) | 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(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.80(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.80(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.80(b)(7) | 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 11 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