Overview
- 15 public-safe observations are available for this inspection.
- 5 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.
5 Aug 2015
21 CFR 111.205(b)(1)
Master manufacturing record-specifications; packaged, label
Cited by Martin R Vowell, Sarah M Meng
5 Aug 2015
21 CFR 111.205(b)(1)
Master manufacturing record-specifications; packaged, label
Cited by Martin R Vowell, Sarah M Meng
5 Aug 2015
21 CFR 111.205(b)(1)
Master manufacturing record-specifications; packaged, label
Cited by Martin R Vowell, Sarah M Meng
5 Aug 2015
21 CFR 211.180(e)(1)
Review of representative number of batches
Cited by Martin R Vowell, Sarah M Meng
5 Aug 2015
21 CFR 211.180(e)(1)
Review of representative number of batches
Cited by Martin R Vowell, Sarah M Meng
Inspected site
FPFuture Pak LLCWixom, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.205(b)(1) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.180(e)(1) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 3x |
Full 483 report
Get the verbatim text of all 15 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