Overview
- 4 public-safe observations are available for this inspection.
- 4 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.
2 Feb 2012
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by William A Warnick, Paula J Bretz, Ernest Bizjak, Rabin N Ghoshal
2 Feb 2012
21 CFR 211.25(a)
Training , Education , Experience overall
Cited by William A Warnick, Paula J Bretz, Ernest Bizjak, Rabin N Ghoshal
2 Feb 2012
21 CFR 211.42(c)
Defined areas of adequate size for operations
Cited by William A Warnick, Paula J Bretz, Ernest Bizjak, Rabin N Ghoshal
2 Feb 2012
21 CFR 211.42(c)(5)
Mfg / Processing Operations Area
Cited by William A Warnick, Paula J Bretz, Ernest Bizjak, Rabin N Ghoshal
Inspected site
MPMylan Pharmaceuticals IncMorgantown, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(5) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 4 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