Overview
- 11 public-safe observations are available for this inspection.
- 11 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.
22 Apr 2013
21 CFR 111.70(d)
Specifications - labels, packaging
Cited by Jamie M Bumpas, Elisa M Fleming
22 Apr 2013
21 CFR 111.120(e)
Quality control operations - quarantine
Cited by Jamie M Bumpas, Elisa M Fleming
22 Apr 2013
21 CFR 111.123
Quality control operations - master, batch, manufacturing
Cited by Jamie M Bumpas, Elisa M Fleming
22 Apr 2013
21 CFR 111.127
Quality control operations - packaging, labeling
Cited by Jamie M Bumpas, Elisa M Fleming
Inspected site
FPFaspac Packaging LPDallas, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.120(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.123 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.127 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.160(d)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.205(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.255(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.103 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.125(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 11 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