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.
20 Nov 2012
21 CFR 111.12
Personnel - quality control personnel - qualified
Cited by Brandon J Brookens, Maureen A Wentzel
20 Nov 2012
21 CFR 111.25(c)
Procedures - equipment - cleaning, sanitizing
Cited by Brandon J Brookens, Maureen A Wentzel
20 Nov 2012
21 CFR 111.27(d)
Equipment - maintain, clean, sanitize
Cited by Brandon J Brookens, Maureen A Wentzel
Inspected site
HNHi-Tech Nutraceuticals LLCReedsville, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.12 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.15(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.15(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.25(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.27(d) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 5 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