Overview
- 5 public-safe observations are available for this inspection.
- 4 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.
Sanitation Controls Procedures
Cited by Kathryn A Guardiola, Dylan C Grippi, Chelsea J Falkowski, Chelsea J Snider, Kathryn A Cutajar
Allergen Controls Monitoring Proced: Establish Implement
Cited by Kathryn A Guardiola, Dylan C Grippi, Chelsea J Falkowski, Chelsea J Snider, Kathryn A Cutajar
Process Controls Corrective Action Proced: Estab Implement
Cited by Kathryn A Guardiola, Dylan C Grippi, Chelsea J Falkowski, Chelsea J Snider, Kathryn A Cutajar
Sanitation Controls Corrective Action Proced: Estab Implemnt
Cited by Kathryn A Guardiola, Dylan C Grippi, Chelsea J Falkowski, Chelsea J Snider, Kathryn A Cutajar
Process Controls Validation Not Performed
Cited by Kathryn A Guardiola, Dylan C Grippi, Chelsea J Falkowski, Chelsea J Snider, Kathryn A Cutajar
Inspected site
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 117.150(a)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 117.135(c)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.145(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.160(a) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 5 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