Overview
- 20 public-safe observations are available for this inspection.
- 20 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.
21 May 2021
21 CFR 111.103
Written procedures - quality control operations
Cited by Dariusz Galezowski, Justin A Boyd
21 May 2021
21 CFR 111.113(a)(1)
QC production, process control; material review, disposition
Cited by Dariusz Galezowski, Justin A Boyd
21 May 2021
21 CFR 111.113(b)(2)
Quality control - reject; specification not met
Cited by Dariusz Galezowski, Justin A Boyd
21 May 2021
21 CFR 111.205(a)
Master manufacturing record - unique formulation
Cited by Dariusz Galezowski, Justin A Boyd
Inspected site
SNSalud Natural Entrepreneur, Inc.Waukegan, 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 111.113(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.113(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.205(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.255(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.255(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.260(e) | 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 111.27(a)(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 111.455(a) | 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(b)(3) | 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(a)(1)(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 120.8(a) | Cited across public-safe Form 483 observations | 1x |
Source document
PDF
PDF available
Form 483 source document
The source document is available to authorized Atlas users.
Full 483 report
Get the verbatim text of all 20 observations
The source PDF, 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