Overview
- 6 public-safe observations are available for this inspection.
- 6 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.
16 Apr 2012
21 CFR 211.68(a)
Calibration/Inspection/Checking not done
Cited by Virgilio F Pacio, Vashti E Bocker
16 Apr 2012
21 CFR 211.100(b)
SOPs not followed / documented
Cited by Virgilio F Pacio, Vashti E Bocker
16 Apr 2012
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Virgilio F Pacio, Vashti E Bocker
16 Apr 2012
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Virgilio F Pacio, Vashti E Bocker
Inspected site
AMAlliance Medical Products, Inc.Irvine, United States
Inspection team
VEVashti E Bocker
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 211.180(e)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(iii) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | 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 6 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