Overview
- 14 public-safe observations are available for this inspection.
- 14 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 2008
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Michele L Obert, Danial S Hutchison, Matthew R Sleeter, Warren J Lopicka, Gwyn G Dickinson
14 Nov 2008
21 CFR 211.42(b)
Product flow through building is inadequate
Cited by Michele L Obert, Danial S Hutchison, Matthew R Sleeter, Warren J Lopicka, Gwyn G Dickinson
14 Nov 2008
21 CFR 211.56(b)
Written sanitation procedures lacking
Cited by Michele L Obert, Danial S Hutchison, Matthew R Sleeter, Warren J Lopicka, Gwyn G Dickinson
14 Nov 2008
21 CFR 211.67(a)
Cleaning / Sanitizing / Maintenance
Cited by Michele L Obert, Danial S Hutchison, Matthew R Sleeter, Warren J Lopicka, Gwyn G Dickinson
14 Nov 2008
21 CFR 211.67(b)(3)
Cleaning SOPs/instructions
Cited by Michele L Obert, Danial S Hutchison, Matthew R Sleeter, Warren J Lopicka, Gwyn G Dickinson
Inspected site
MPMPP PHARMA LLCKansas City, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.137(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(8) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.56(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b)(3) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 14 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