Overview
- 10 public-safe observations are available for this inspection.
- 10 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.
14 Mar 2012
21 CFR 111.127
Quality control operations - packaging, labeling
Cited by Emily J Orban, Michele L Forster, Jeffrey D Meng
14 Mar 2012
21 CFR 111.140(b)(1)
Records - quality control operations; responsibilities
Cited by Emily J Orban, Michele L Forster, Jeffrey D Meng
14 Mar 2012
21 CFR 111.415(f)(1)
Batch-lot,control number packaged, labeled dietary supplemen
Cited by Emily J Orban, Michele L Forster, Jeffrey D Meng
14 Mar 2012
21 CFR 111.430(b)
Records - packaging, labeling operations
Cited by Emily J Orban, Michele L Forster, Jeffrey D Meng
14 Mar 2012
21 CFR 111.475(b)(1)
Written procedures - holding; distributing
Cited by Emily J Orban, Michele L Forster, Jeffrey D Meng
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 111.127 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.140(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.415(f)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.430(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 111.553 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.122(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.130 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.150(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 10 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