Overview
- 18 public-safe observations are available for this inspection.
- 17 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 Mar 2010
21 CFR 211.25(a)
Training--operations, GMPs, written procedures
Cited by Sangeeta M Khurana, Heika R Tait
16 Mar 2010
21 CFR 211.67(a)
Cleaning / Sanitizing / Maintenance
Cited by Sangeeta M Khurana, Heika R Tait
16 Mar 2010
21 CFR 211.67(b)
Written procedures not established/followed
Cited by Sangeeta M Khurana, Heika R Tait
16 Mar 2010
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Sangeeta M Khurana, Heika R Tait
16 Mar 2010
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Sangeeta M Khurana, Heika R Tait
Inspected site
SUSilgan Unicep Packaging, LLC.Sandpoint, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.194(a)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(7) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(8) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 18 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