Overview
- 5 public-safe observations are available for this inspection.
- 5 structured CFR citations are represented.
- 3 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
5 Mar 2018
21 CFR 111.105
Ensure quality; package, labeled, master record
Cited by David A Gonzalez, Jessica M Ector, Christine L Williams
5 Mar 2018
21 CFR 111.12(b)
Personnel - quality control operations; responsibilities
Cited by David A Gonzalez, Jessica M Ector, Christine L Williams
5 Mar 2018
21 CFR 111.75(a)(1)(i)
Component - verify identity, dietary ingredient
Cited by David A Gonzalez, Jessica M Ector, Christine L Williams
5 Mar 2018
21 CFR 111.205(a)
Master manufacturing record - unique formulation
Cited by David A Gonzalez, Jessica M Ector, Christine L Williams
5 Mar 2018
21 CFR 111.255(b)
Batch record - complete
Cited by David A Gonzalez, Jessica M Ector, Christine L Williams
Inspected site
NHNew Herb Health, LLCMead, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.105 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.12(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.205(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.255(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(a)(1)(i) | 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