Overview
- 6 public-safe observations are available for this inspection.
- 6 structured CFR citations are represented.
- 4 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
19 Feb 2019
21 CFR 117.130(a)(1)
Hazard Analysis - Identification of Hazard
Cited by Joshua L Gibbs, Rupa Pradhan, Alysia M Salonia, Charles R Clavet
19 Feb 2019
21 CFR 117.145(a)
Sanitation Controls Monitoring Proced: Establish Implement
Cited by Joshua L Gibbs, Rupa Pradhan, Alysia M Salonia, Charles R Clavet
19 Feb 2019
21 CFR 117.150(a)(1)
Sanitation Controls Corrective Action Proced: Estab Implemnt
Cited by Joshua L Gibbs, Rupa Pradhan, Alysia M Salonia, Charles R Clavet
19 Feb 2019
21 CFR 117.135(a)(1)
Preventive Controls - Identify
Cited by Joshua L Gibbs, Rupa Pradhan, Alysia M Salonia, Charles R Clavet
19 Feb 2019
21 CFR 117.145(c)(1)
Sanitation Controls - Monitoring Records
Cited by Joshua L Gibbs, Rupa Pradhan, Alysia M Salonia, Charles R Clavet
Inspected site
SISunshine International Foods, Inc.Methuen, United States
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 117.135(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 117.145(c)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.150(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.165(b) | Cited across public-safe Form 483 observations | 1x |
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