Overview
- 4 public-safe observations are available for this inspection.
- 4 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.
6 Feb 2013
21 CFR 111.153
Written procedures - product received; packaging, labeling
Cited by Michele L Forster
6 Feb 2013
21 CFR 111.415(g)
Representative sample - packaged, labeled dietary supplement
Cited by Michele L Forster
6 Feb 2013
21 CFR 111.560(c)
Product complaint -investigate, findings, follow-up
Cited by Michele L Forster
Inspected site
H&H & L Jerch Sales, Inc.South Haven, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.153 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.255(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.415(g) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.560(c) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 4 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