Overview
- 10 public-safe observations are available for this inspection.
- 10 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.
20 Feb 2015
21 CFR 211.100(a)
Changes to Procedures Not Reviewed, Approved
Cited by Michele L Obert, Ashley A Mutawakkil, Daniel R Hurt, Bryan S Roddy
20 Feb 2015
21 CFR 211.103
Actual vs. theoretical yields not determined
Cited by Michele L Obert, Ashley A Mutawakkil, Daniel R Hurt, Bryan S Roddy
20 Feb 2015
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Michele L Obert, Ashley A Mutawakkil, Daniel R Hurt, Bryan S Roddy
20 Feb 2015
21 CFR 211.160(b)(2)
In-process samples representative, identified properly
Cited by Michele L Obert, Ashley A Mutawakkil, Daniel R Hurt, Bryan S Roddy
20 Feb 2015
21 CFR 211.160(b)(4)
Calibration - at intervals, written program, remedial action
Cited by Michele L Obert, Ashley A Mutawakkil, Daniel R Hurt, Bryan S Roddy
Inspected site
LILloyd Inc. of IowaShenandoah, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.103 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 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 211.166(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(3) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 10 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