Overview
- 6 public-safe observations are available for this inspection.
- 6 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.
6 May 2011
21 CFR 211.42(c)(10)(iv)
Environmental Monitoring System
Cited by Jennifer M Gogley, Carla J Lundi, John A Gonzalez
6 May 2011
21 CFR 211.67(a)
Cleaning / Sanitizing / Maintenance
Cited by Jennifer M Gogley, Carla J Lundi, John A Gonzalez
6 May 2011
21 CFR 211.87
Retest of approved components/containers/closures
Cited by Jennifer M Gogley, Carla J Lundi, John A Gonzalez
6 May 2011
21 CFR 211.100(b)
SOPs not followed / documented
Cited by Jennifer M Gogley, Carla J Lundi, John A Gonzalez
6 May 2011
21 CFR 211.110(a)
Written in-process control procedures
Cited by Jennifer M Gogley, Carla J Lundi, John A Gonzalez
Inspected site
APAmphastar Pharmaceuticals, Inc.Rancho Cucamonga, 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 211.113(b) | 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 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.87 | 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