Overview
- 11 public-safe observations are available for this inspection.
- 10 structured CFR citations are represented.
- 1 investigator is tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
5 Oct 2010
21 CFR 211.56(a)
Sanitation--buildings not clean, free of infestation
Cited by Anita R Michael
Inspected site
MPMarlex Pharmaceuticals, Inc.New Castle, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.56(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.142(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.44 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.46(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.56(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.82(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 11 observations
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