Overview
- 5 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.
5 Jul 2018
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Eileen A Liu, Gloria J Baca, Tracy K Li
5 Jul 2018
21 CFR 211.160(a)
Following/documenting laboratory controls
Cited by Eileen A Liu, Gloria J Baca, Tracy K Li
5 Jul 2018
21 CFR 211.160(b)(4)
Establishment of calibration procedures
Cited by Eileen A Liu, Gloria J Baca, Tracy K Li
5 Jul 2018
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Eileen A Liu, Gloria J Baca, Tracy K Li
5 Jul 2018
21 CFR 211.67(b)(2)
Cleaning SOPs/schedules
Cited by Eileen A Liu, Gloria J Baca, Tracy K Li
Inspected site
GIGenentech, Inc.Hillsboro, 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(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b)(2) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 5 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