Overview
- 6 public-safe observations are available for this inspection.
- 5 structured CFR citations are represented.
- 3 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
23 Jun 2011
21 CFR 211.42(c)
Defined areas of adequate size for operations
Cited by Peter E Baker, Lance M De Souza, Carl Lee
23 Jun 2011
21 CFR 211.42(c)(10)
Aseptic Processing Area
Cited by Peter E Baker, Lance M De Souza, Carl Lee
23 Jun 2011
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Peter E Baker, Lance M De Souza, Carl Lee
23 Jun 2011
21 CFR 211.160(a)
Following/documenting laboratory controls
Cited by Peter E Baker, Lance M De Souza, Carl Lee
23 Jun 2011
21 CFR 211.192
No written record of investigation
Cited by Peter E Baker, Lance M De Souza, Carl Lee
Inspected site
GIGenentech, Inc.South San Francisco, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(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) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 6 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