Yusef Manufacturing Laboratories, LLC
FDA inspection history in Clearfield, Utah, 2016 to 2022
- 4
- Form 483s
- 2
- Warning letters
Every document, by year
- Form 483
- Warning letter
2016: one Form 483; 2017: one warning letter; 2019: one Form 483; 2021: one Form 483; 2022: one Form 483 and one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2016–22Four Form 483s and two warning letters, at Clearfield, Utah.
- 2021The longest 483 on file: 30 observations over 13 pages at Clearfield, Utah.
Cited most
Across all Yusef Manufacturing Laboratories observations on file
- 21 CFR 211.165(a)Testing and release for distribution7
- 21 CFR 211.194(a)(1)Laboratory records5
- 21 CFR 211.68(a)Automatic, mechanical, and electronic equipment5
- 21 CFR 211.160(a)General requirements4
- 21 CFR 211.166(a)Stability testing4
The complete Yusef Manufacturing Laboratories file.
All 6 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Clearfield, Utah
Four Form 483s and two warning letters · 2016 to 2022 · 61 observations
Latest: Form 483, Nov 4, 2022 →
Documents
6 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-11-04 | 483 Form 483 | Clearfield, Utah | 12 | $99 |
| 2022-02-08 | Warning letter Warning letter | Clearfield, Utah | — | $99 |
| 2021-09-24 | 483 Form 483 | Clearfield, Utah | 30 | $99 |
| 2019-09-13 | 483 Form 483 | Clearfield, Utah | 3 | $99 |
| 2017-05-25 | Warning letter Warning letter | Clearfield, Utah | — | $99 |
| 2016-05-26 | 483 Form 483 | Clearfield, Utah | 16 | $99 |
Investigators on these documents
Alan P. Kurtzberg (1)Andrew Le (1)Kham Phommachanh (1)Lisa Shin (1)Nayan J. Patel (1)Rafeeq Habeeb (1)Tenzin Jangchup (1)Zachary L. Stamm (1)
FEI number 3004845420 · most recent document Nov 4, 2022
About Yusef Manufacturing Laboratories, LLC
How many FDA Form 483s has Yusef Manufacturing Laboratories, LLC received?
FDA Intel has 4 Form 483s on file for Yusef Manufacturing Laboratories, LLC; the most recent is dated Nov 4, 2022.
When was Yusef Manufacturing Laboratories, LLC last inspected by FDA?
The most recent FDA inspection document on file for Yusef Manufacturing Laboratories, LLC is a Form 483 dated Nov 4, 2022, for the site in Clearfield, Utah.
What did FDA cite at Yusef Manufacturing Laboratories, LLC?
The regulations cited most in the observations on file for Yusef Manufacturing Laboratories, LLC are 21 CFR 211.165(a) (Testing and release for distribution), 7 times; 21 CFR 211.194(a)(1) (Laboratory records), 5 times; 21 CFR 211.68(a) (Automatic, mechanical, and electronic equipment), 5 times.
Has Yusef Manufacturing Laboratories, LLC received an FDA warning letter?
Yes. FDA Intel has 2 FDA warning letters on file for Yusef Manufacturing Laboratories, LLC; the most recent is dated Feb 8, 2022.