Overview
- 5 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.
6 Aug 2021
21 CFR 111.105(h)
Quality control - production, process control
Cited by Martin R Vowell, Geneve M Parks
6 Aug 2021
21 CFR 111.130(a)(2)
Returned dietary supplement; tests, examinations; results
Cited by Martin R Vowell, Geneve M Parks
6 Aug 2021
21 CFR 111.560(b)
Quality control, review, approve; investigate, follow-up
Cited by Martin R Vowell, Geneve M Parks
Inspected site
TLTotal Life ChangesIra, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.105(h) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.130(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.165(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.453 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.560(b) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 5 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