Overview
- 9 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-04-11.
At a glance
Inspections
9
Form 483s
6
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 17 Mar 2025 – 11 Apr 2025 | Foods & Cosmetics | 483 | View 483 → |
| 20 May 2024 – 20 Jun 2024 | Foods & Cosmetics | 483 | View 483 → |
| 10 Jul 2023 – 25 Sep 2023 | Foods & Cosmetics | 483 | View 483 → |
| 15 Mar 2023 | Foods & Cosmetics | Clean | |
| 10 May 2021 – 21 May 2021 | Foods & Cosmetics | 483 | View 483 → |
| 20 Aug 2019 – 22 Jan 2020 | Foods & Cosmetics | 483 | View 483 → |
| 20 Aug 2019 – 14 Nov 2019 | Foods & Cosmetics | Clean | |
| 31 Jul 2018 – 28 Aug 2018 | Foods & Cosmetics | 483 | View 483 → |
| 26 May 2015 – 6 Jul 2015 | Foods & Cosmetics | WL |
Observations on record
Form 483 observations cited at this site, most recent first.
Written procedures - establish; quality control operations
Cited by Dariusz Galezowski, Jennifer R Johnson, Brian J Davis
Quality control - reject; specification not met
Cited by Dariusz Galezowski, Jennifer R Johnson, Brian J Davis
Master manufacturing record - record requirements
Cited by Dariusz Galezowski, Jennifer R Johnson, Brian J Davis
Records - written procedures holding and distribution; product distribution
Cited by Dariusz Galezowski, Jennifer R Johnson, Brian J Davis
Specifications - components
Cited by Dariusz Galezowski, Jennifer R Johnson, Brian J Davis
Investigators
FDA investigators tied to this site in the record.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.70(e) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 111.103 | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 111.113(b)(2) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 111.260(e) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 111.205(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.210(h)(5) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.75(a)(1)(i) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.165(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.210(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.255(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.255(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.260(j) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.260(m) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.27(a)(4) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.455(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.70(b)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.70(b)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.70(b)(3) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.75(a)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.75(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.105(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.113(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.113(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.123(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.123(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.155(c)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.205(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.210 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.210(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.210(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.210(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.210(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.210(g) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.210(h)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.210(h)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.210(h)(3)(ii)(B) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.25(a) | 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)(1)(i) | 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(d)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.365 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.475(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(h) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(h)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.77(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.95(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.95(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 120.8(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Salud Natural Entrepreneur, Inc.'s 6 Form 483s
Source PDFs 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