Overview
- 4 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2016-06-22.
At a glance
Inspections
4
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 6 Jun 2016 – 22 Jun 2016 | Foods & Cosmetics | 483 | View 483 → |
| 8 Sep 2014 – 30 Sep 2014 | Foods & Cosmetics | 483 | View 483 → |
| 2 Apr 2014 – 10 Apr 2014 | Foods & Cosmetics | 483 | View 483 → |
| 11 Sep 2012 | Not recorded | WL | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
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
Investigators
FDA investigators tied to this site in the record.
Marc Balzarini1 insp.
Marinee Flores-Marrero1 insp.
Leslie A Jackanicz1 insp.
Leslie A Cartmill1 insp.
Rachel Gomez1 insp.
Rachel Peters1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.75(a)(2)(ii)(A) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.65 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.70(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.75(a)(1)(i) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1.225 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.103 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.15(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.20(d)(1)(iv) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.20(d)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.205(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.205(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.255(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.260(j) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.260(k) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.260(l)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.27(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.27(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.30(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.30(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.303 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.35(b)(6) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.415(f)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(g) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(c)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(c)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(c)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.83(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.6(d) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Sunset Natural Products Inc.'s 4 Form 483s
Verbatim observations and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat