Overview
- 6 public-safe observations are available for this inspection.
- 6 structured CFR citations are represented.
- 5 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
Hazard Analysis - Identification of Hazard
Cited by Laura A Munsterman, Carla R Hinz, Jessica M Ector, Cesar A Herrera, Andrew J Gonzales
HACCP training or qualification
Cited by Laura A Munsterman, Carla R Hinz, Jessica M Ector, Cesar A Herrera, Andrew J Gonzales
Signed and dated
Cited by Laura A Munsterman, Carla R Hinz, Jessica M Ector, Cesar A Herrera, Andrew J Gonzales
Process Controls Monitoring Procedures: Establish Implement
Cited by Laura A Munsterman, Carla R Hinz, Jessica M Ector, Cesar A Herrera, Andrew J Gonzales
Allergen Controls Verif Procedures: Establish Implement
Cited by Laura A Munsterman, Carla R Hinz, Jessica M Ector, Cesar A Herrera, Andrew J Gonzales
Inspected site
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 117.130(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.145(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.165(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.10 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.6(c)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.6(d) | Cited across public-safe Form 483 observations | 1x |
Source document
Form 483 source document
The source document is available to authorized Atlas users.
Full 483 report
Get the verbatim text of all 6 observations
The source PDF and 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