Overview
- 14 public-safe observations are available for this inspection.
- 14 structured CFR citations are represented.
- 1 investigator is tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
17 Sep 2010
21 CFR 111.103
Written procedures - quality control operations
Cited by Jacqueline S Warner
17 Sep 2010
21 CFR 111.110(c)
Quality control operations - tests, examinations; results
Cited by Jacqueline S Warner
Inspected site
HNHerba Natural Products, IncBrooklyn, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.103 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.105(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.110(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.123(a)(8) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.140(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.15(d)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.155(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.16 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.310(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.455(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.465(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.475(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.503 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.553 | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 14 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