Overview
- 8 public-safe observations are available for this inspection.
- 8 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.
12 Dec 2012
21 CFR 314.80(b)
Failure to develop written procedures
Cited by Sonia R Peterson, Caryn M Mcnab, Maxyne T Lam
12 Dec 2012
21 CFR 314.80(c)
Failure by applicant to report ADE
Cited by Sonia R Peterson, Caryn M Mcnab, Maxyne T Lam
12 Dec 2012
21 CFR 314.80(c)(1)(i)
Late submission of 15-day report
Cited by Sonia R Peterson, Caryn M Mcnab, Maxyne T Lam
12 Dec 2012
21 CFR 314.80(e)
Failure to report post-marketing study ADEs
Cited by Sonia R Peterson, Caryn M Mcnab, Maxyne T Lam
12 Dec 2012
21 CFR 600.80(b)
Review of Adverse Experiences - SOPs
Cited by Sonia R Peterson, Caryn M Mcnab, Maxyne T Lam
Inspected site
AIAmgen, Inc.Thousand Oaks, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 314.80(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.80(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.80(c)(1)(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.80(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 600.80(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 600.80(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 600.80(c)(1)(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 600.80(c)(1)(ii) | Cited across public-safe Form 483 observations | 1x |
Source document
PDF
PDF available
Form 483 source document
The source document is available to authorized Atlas users.
Full 483 report
Get the verbatim text of all 8 observations
The source PDF and 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