Overview
- 4 public-safe observations are available for this inspection.
- 4 structured CFR citations are represented.
- 2 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
22 Jun 2016
21 CFR 111.70(e)
Specifications - identity, purity, strength, composition
Cited by Marc Balzarini, Marinee Flores-Marrero
22 Jun 2016
21 CFR 111.75(c)(3)
Specifications met limits on contamination ; basis
Cited by Marc Balzarini, Marinee Flores-Marrero
22 Jun 2016
21 CFR 111.103
Written procedures - quality control operations
Cited by Marc Balzarini, Marinee Flores-Marrero
22 Jun 2016
21 CFR 111.303
Written procedures - tests, examinations; specifications met
Cited by Marc Balzarini, Marinee Flores-Marrero
Inspected site
SNSunset Natural Products Inc.Miami, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.103 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.303 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(c)(3) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 4 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