Overview
- 12 public-safe observations are available for this inspection.
- 6 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.
6 Aug 2021
21 CFR 111.113(a)(5)
QC returned dietary supplement; material review, disposition
Cited by Amanda N Schaupp, Natalie Rodriguez
6 Aug 2021
21 CFR 111.113(a)(5)
QC returned dietary supplement; material review, disposition
Cited by Amanda N Schaupp, Natalie Rodriguez
6 Aug 2021
21 CFR 111.127(e)
QC ops packaging, labeling; material review, disposition
Cited by Amanda N Schaupp, Natalie Rodriguez
6 Aug 2021
21 CFR 111.127(e)
QC ops packaging, labeling; material review, disposition
Cited by Amanda N Schaupp, Natalie Rodriguez
6 Aug 2021
21 CFR 111.70(b)(1)
Specifications - component identity
Cited by Amanda N Schaupp, Natalie Rodriguez
Inspected site
ATActiveHerb Technology, IncSan Diego, United States
Inspection team
NRNatalie Rodriguez
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 | 2x |
| 21 CFR 111.127(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.70(b)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.70(b)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.70(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.75(a)(2) | Cited across public-safe Form 483 observations | 2x |
Full 483 report
Get the verbatim text of all 12 observations
The full inspection record, as Atlas holds it, 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