Overview
- 7 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.
9 Jul 2015
21 CFR 211.100(b)
SOPs not followed / documented
Cited by Robert J Ham, Tiara N Brown-Crosen
9 Jul 2015
21 CFR 211.110(b)
In-process materials specifications
Cited by Robert J Ham, Tiara N Brown-Crosen
9 Jul 2015
21 CFR 211.115(a)
Reprocessing procedures not written or followed
Cited by Robert J Ham, Tiara N Brown-Crosen
9 Jul 2015
21 CFR 211.182
Chronological Order of Equipment Log Entries
Cited by Robert J Ham, Tiara N Brown-Crosen
9 Jul 2015
21 CFR 211.182
Specific information required in individual logs
Cited by Robert J Ham, Tiara N Brown-Crosen
Inspected site
LPLegacy Pharmaceutical Packaging, LLCEarth City, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.182 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.115(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 7 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