Overview
- 3 public-safe observations are available for this inspection.
- 3 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.
25 May 2012
21 CFR 111.430(b)
Records - packaging, labeling operations
Cited by Robert E Spear, Jamie M Bumpas
25 May 2012
21 CFR 111.475(b)(1)
Written procedures - holding; distributing
Cited by Robert E Spear, Jamie M Bumpas
25 May 2012
21 CFR 111.535(b)(1)
Records - returned dietary supplement: written procedures
Cited by Robert E Spear, Jamie M Bumpas
Inspected site
FIFulfillPlus, Inc.Houston, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.430(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.475(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.535(b)(1) | 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