Overview
- 5 public-safe observations are available for this inspection.
- 5 structured CFR citations are represented.
- 2 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
12 Feb 2019
21 CFR 211.100(b)
SOPs not followed / documented
Cited by Ashar P Parikh, Philip F Istafanos
12 Feb 2019
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Ashar P Parikh, Philip F Istafanos
12 Feb 2019
21 CFR 211.160(a)
Deviations from laboratory control requirements
Cited by Ashar P Parikh, Philip F Istafanos
12 Feb 2019
21 CFR 211.188
Prepared for each batch, include complete information
Cited by Ashar P Parikh, Philip F Istafanos
12 Feb 2019
21 CFR 211.192
No written record of investigation
Cited by Ashar P Parikh, Philip F Istafanos
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 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | 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 5 observations
The source PDF, 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