Overview
- 13 public-safe observations are available for this inspection.
- 13 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 Jun 2010
21 CFR 211.25(a)
Training--operations, GMPs, written procedures
Cited by Diane C Van Leeuwen, Jennifer M Gogley, Caryn M Mcnab, Maria C Fermin
2 Jun 2010
21 CFR 211.42(c)
Defined areas of adequate size for operations
Cited by Diane C Van Leeuwen, Jennifer M Gogley, Caryn M Mcnab, Maria C Fermin
2 Jun 2010
21 CFR 211.42(c)(10)(iv)
Environmental Monitoring System
Cited by Diane C Van Leeuwen, Jennifer M Gogley, Caryn M Mcnab, Maria C Fermin
2 Jun 2010
21 CFR 211.42(c)(10)(vi)
Equipment to control conditions
Cited by Diane C Van Leeuwen, Jennifer M Gogley, Caryn M Mcnab, Maria C Fermin
2 Jun 2010
21 CFR 211.63
Equipment Design, Size and Location
Cited by Diane C Van Leeuwen, Jennifer M Gogley, Caryn M Mcnab, Maria C Fermin
Inspected site
MPMcGuff Pharmaceuticals, Inc.Santa Ana, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.113(b) | 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(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | 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)(10)(iv) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(vi) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(6) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 13 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