Overview
- 8 public-safe observations are available for this inspection.
- 8 structured CFR citations are represented.
- 4 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
9 Oct 2013
21 CFR 110.10(b)(7)
Storage of personal items
Cited by Jonathan R Campos, Steven P Allen, Lori Gioia, Janete A Oliveira
9 Oct 2013
21 CFR 110.35(a)
Cleaning and sanitizing operations
Cited by Jonathan R Campos, Steven P Allen, Lori Gioia, Janete A Oliveira
9 Oct 2013
21 CFR 110.35(c)
Lack of effective pest exclusion
Cited by Jonathan R Campos, Steven P Allen, Lori Gioia, Janete A Oliveira
9 Oct 2013
21 CFR 111.135
Quality control operations - product complaints
Cited by Jonathan R Campos, Steven P Allen, Lori Gioia, Janete A Oliveira
9 Oct 2013
21 CFR 111.403
Written procedures - labeling operations
Cited by Jonathan R Campos, Steven P Allen, Lori Gioia, Janete A Oliveira
Inspected site
SFStorehouse Foods, d.b.a. Swedish Bitters Herb CompanyConcordia, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 110.10(b)(7) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.35(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.35(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.135 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.403 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.453 | 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 8 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