Overview
- 9 public-safe observations are available for this inspection.
- 3 structured CFR citations are represented.
- 4 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
4 Sep 2015
21 CFR 110.80(a)(1)
Inspection of containers and carriers upon receipt
Cited by Tiara N Brown-Crosen, Steven P Allen, Dwight D Ferguson, Joseph R Lambert
4 Sep 2015
21 CFR 110.80(a)(1)
Inspection of containers and carriers upon receipt
Cited by Tiara N Brown-Crosen, Steven P Allen, Dwight D Ferguson, Joseph R Lambert
4 Sep 2015
21 CFR 110.80(a)(1)
Inspection of containers and carriers upon receipt
Cited by Tiara N Brown-Crosen, Steven P Allen, Dwight D Ferguson, Joseph R Lambert
4 Sep 2015
21 CFR 110.80(b)(9)
Proper reconditioning
Cited by Tiara N Brown-Crosen, Steven P Allen, Dwight D Ferguson, Joseph R Lambert
4 Sep 2015
21 CFR 110.80(b)(9)
Proper reconditioning
Cited by Tiara N Brown-Crosen, Steven P Allen, Dwight D Ferguson, Joseph R Lambert
Inspected site
ALAmerican Laboratories Pharma, LLCOmaha, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 110.80(a)(1) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 110.80(b)(9) | Cited across public-safe Form 483 observations | 3x |
| FDCA 417(d)(1)(A) | Cited across public-safe Form 483 observations | 3x |
Full 483 report
Get the verbatim text of all 9 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