Overview
- 2 public-safe observations are available for this inspection.
- 2 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.
23 Mar 2023
21 CFR 111.155(e)
Components - contamination, deterioration, mix-ups
Cited by Susan M Taylor, Keri U Walker
23 Mar 2023
21 CFR 111.210(h)(2)
Master manufacturing record - sampling, tests, examinations
Cited by Susan M Taylor, Keri U Walker
Inspected site
HNHi-Tech Nutraceuticals,LLCSuwanee, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.155(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.210(h)(2) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 2 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