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.
5 Apr 2016
21 CFR 211.160(b)(4)
Calibration - at intervals, written program, remedial action
Cited by Adetutu M Gidado, Nancy M Espinal
5 Apr 2016
21 CFR 211.192
No written record of investigation
Cited by Adetutu M Gidado, Nancy M Espinal
5 Apr 2016
21 CFR 211.194(a)(4)
Data secured in course of each test
Cited by Adetutu M Gidado, Nancy M Espinal
5 Apr 2016
21 CFR 211.68(b)
Computer control of master formula records
Cited by Adetutu M Gidado, Nancy M Espinal
Inspected site
ATAlliance Technologies, LLCMonmouth Junction, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | 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