Overview
- 6 public-safe observations are available for this inspection.
- 6 structured CFR citations are represented.
- 1 investigator is tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
21 Mar 2012
21 CFR 111.75(a)(1)(i)
Component - verify identity, dietary ingredient
Cited by Jennifer A Robinson
21 Mar 2012
21 CFR 111.113(a)(5)
QC returned dietary supplement; material review, disposition
Cited by Jennifer A Robinson
21 Mar 2012
21 CFR 111.140(b)(1)
Records - quality control operations; responsibilities
Cited by Jennifer A Robinson
21 Mar 2012
21 CFR 111.475(b)(1)
Written procedures - holding; distributing
Cited by Jennifer A Robinson
Inspected site
PSPure Solutions, Inc.Tampa, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.113(a)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.140(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.410(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 111.570(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(a)(1)(i) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 6 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