SnugZ/USA, LLC
FDA inspection history in West Jordan, Utah, 2018 to 2026
- 2
- Form 483s
- 1
- Warning letter
- 1
- Close-out
Every document, by year
- Warning letter
- Form 483
- Close-out
2018: one Form 483; 2019: one close-out letter; 2021: one Form 483; 2026: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2018–21Two Form 483s and one close-out letter, at West Jordan, Utah.
- 2021The longest 483 on file: 18 observations over 7 pages at West Jordan, Utah.
- 2026One warning letter, at West Jordan, Utah.
Cited most
Across all SnugZ/USA observations on file
- 21 CFR 211.160(b)General requirements3
- 21 CFR 211.84(c)(2)Testing and approval or rejection of components, drug product containers, and closures3
- 21 CFR 211.100(a)Written procedures; deviations2
- 21 CFR 211.113(a)Control of microbiological contamination2
- 21 CFR 211.166(a)(3)Stability testing2
The complete SnugZ/USA file.
All 4 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
West Jordan, Utah
Two Form 483s, one warning letter and one close-out letter · 2018 to 2026 · 32 observations
Latest: Warning letter, Sep 28, 2026 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2026-09-28 | Warning letter Warning letter | West Jordan, Utah | — | $99 |
| 2021-09-17 | 483 Form 483 | West Jordan, Utah | 18 | $99 |
| 2019-06-12 | Close-out Close-out letter | West Jordan, Utah | — | $99 |
| 2018-11-30 | 483 Form 483 | West Jordan, Utah | 14 | $99 |
Investigators on these documents
FEI number 3009188709 · most recent document Sep 28, 2026
About SnugZ/USA, LLC
How many FDA Form 483s has SnugZ/USA, LLC received?
FDA Intel has 2 Form 483s on file for SnugZ/USA, LLC; the most recent is dated Sep 17, 2021.
When was SnugZ/USA, LLC last inspected by FDA?
The most recent FDA inspection document on file for SnugZ/USA, LLC is a Form 483 dated Sep 17, 2021, for the site in West Jordan, Utah.
What did FDA cite at SnugZ/USA, LLC?
The regulations cited most in the observations on file for SnugZ/USA, LLC are 21 CFR 211.160(b) (General requirements), 3 times; 21 CFR 211.84(c)(2) (Testing and approval or rejection of components, drug product containers, and closures), 3 times; 21 CFR 211.100(a) (Written procedures; deviations), 2 times.
Has SnugZ/USA, LLC received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for SnugZ/USA, LLC; the most recent is dated Sep 28, 2026.