Overview
- 8 public-safe observations are available for this inspection.
- 8 structured CFR citations are represented.
- 3 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
2 Nov 2017
21 CFR 117.305
Preventive controls records - general requirements
Cited by Emily J Schramm, Joseph B Cascio, John L Zaccone
2 Nov 2017
21 CFR 117.40(f)
Instruments and Controls
Cited by Emily J Schramm, Joseph B Cascio, John L Zaccone
2 Nov 2017
21 CFR 117.80(c)
Manufacturing, Processing, Packing, Holding - Controls
Cited by Emily J Schramm, Joseph B Cascio, John L Zaccone
2 Nov 2017
21 CFR 117.320
Record Availability
Cited by Emily J Schramm, Joseph B Cascio, John L Zaccone
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 117.10 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.305 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.320 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.35(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.37 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.40(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.80(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.80(c) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 8 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