Overview
- 8 public-safe observations are available for this inspection.
- 4 structured CFR citations are represented.
- 6 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
15 Nov 2019
21 CFR 117.145(a)
Process Controls Monitoring Procedures: Establish Implement
Cited by Marc Balzarini, Paul H Dakin, Sharon Giamberini, Karl D Hezel, Gina Eng, Yazmith Guzman
15 Nov 2019
21 CFR 117.145(b)
Process Controls Monitoring Frequency
Cited by Marc Balzarini, Paul H Dakin, Sharon Giamberini, Karl D Hezel, Gina Eng, Yazmith Guzman
15 Nov 2019
21 CFR 117.150(a)(1)
Process Controls Corrective Action Proced: Estab Implement
Cited by Marc Balzarini, Paul H Dakin, Sharon Giamberini, Karl D Hezel, Gina Eng, Yazmith Guzman
15 Nov 2019
21 CFR 117.40
Equipment and Utensils - Design and Maintenance
Cited by Marc Balzarini, Paul H Dakin, Sharon Giamberini, Karl D Hezel, Gina Eng, Yazmith Guzman
15 Nov 2019
21 CFR 117.145(a)
Process Controls Monitoring Procedures: Establish Implement
Cited by Marc Balzarini, Paul H Dakin, Sharon Giamberini, Karl D Hezel, Gina Eng, Yazmith Guzman
Inspected site
NFNovus FoodsRiviera Beach, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 117.145(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 117.145(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 117.150(a)(1) | 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 8 observations
The full inspection record, as Atlas holds it, 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