Overview
- 6 public-safe observations are available for this inspection.
- 3 structured CFR citations are represented.
- 2 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
29 Aug 2016
21 CFR 110.10(b)(3)
Not washed/sanitized when appropriate
Cited by Karla J Gibler, Natalie A Guidry
29 Aug 2016
21 CFR 110.10(b)(3)
Not washed/sanitized when appropriate
Cited by Karla J Gibler, Natalie A Guidry
29 Aug 2016
21 CFR 110.80(b)(7)
Equipment, containers, utensils
Cited by Karla J Gibler, Natalie A Guidry
Inspected site
HSHerdez S.A. De C.V. Planta El DuqueSan Luis Potosi, Mexico
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 110.10(b)(3) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 110.20(b)(4) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 110.80(b)(7) | Cited across public-safe Form 483 observations | 2x |
Full 483 report
Get the verbatim text of all 6 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