Overview
- 8 public-safe observations are available for this inspection.
- 8 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.
2 Feb 2017
21 CFR 111.103
Written procedures - quality control operations
Cited by Radona R Boutte, Mancia R Walker
2 Feb 2017
21 CFR 111.430(b)
Records - packaging, labeling operations
Cited by Radona R Boutte, Mancia R Walker
2 Feb 2017
21 CFR 111.475(b)(1)
Written procedures - holding; distributing
Cited by Radona R Boutte, Mancia R Walker
2 Feb 2017
21 CFR 111.475(b)(2)
Records - product distribution
Cited by Radona R Boutte, Mancia R Walker
2 Feb 2017
21 CFR 111.503
Written procedures - returned dietary supplement
Cited by Radona R Boutte, Mancia R Walker
Inspected site
DTDetox TransformsAngier, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.103 | Cited across public-safe Form 483 observations | 1x |
| 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 111.475(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.503 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.535(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.553 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.570(b)(2) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 8 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