Overview
- 3 public-safe observations are available for this inspection.
- 3 structured CFR citations are represented.
- 3 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
3 May 2013
21 CFR 110.80(b)(5)
Work-in-progress
Cited by Deniza Karacic, Charles D Brown, Paul E Frazier
3 May 2013
21 CFR 110.93
Storage/transportation of finished goods (contamination)
Cited by Deniza Karacic, Charles D Brown, Paul E Frazier
3 May 2013
21 CFR 113.100(b)
Record form not signed
Cited by Deniza Karacic, Charles D Brown, Paul E Frazier
Inspected site
IPIntermex Products USA, LtdGrand Prairie, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 110.80(b)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.93 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 113.100(b) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 3 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