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.
2 Nov 2018
21 CFR 117.40
Equipment and Utensils - Design and Maintenance
Cited by Grant L Davis, Asha Dwarka
Inspected site
PVProductos Verde Valle S.A. de C.V.Zapopan, Mexico
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 113.60(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 117.35(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 117.40 | 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