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.
9 Feb 2024
21 CFR 111.130(a)
Quality control returned dietary supplement; material review, disposition
Cited by Bailey A Uetrecht, Andrew T Todd
9 Feb 2024
21 CFR 111.140(b)(3)
Records - material review, disposition documentation
Cited by Bailey A Uetrecht, Andrew T Todd
9 Feb 2024
21 CFR 111.205(a)
Master manufacturing record - each batch
Cited by Bailey A Uetrecht, Andrew T Todd
9 Feb 2024
21 CFR 111.70(b)(2)
Specifications-component purity, strength, composition
Cited by Bailey A Uetrecht, Andrew T Todd
9 Feb 2024
21 CFR 111.70(e)
Specifications - identity, purity, strength, composition
Cited by Bailey A Uetrecht, Andrew T Todd
Inspected site
EAEden's Answers IncHolmesville, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.130(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.140(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.205(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(e) | 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