Wasatch Product Development, LLC
FDA inspection history in Draper, Utah, 2004 to 2019
- 4
- Form 483s
Every document, by year
- Form 483
2004: one Form 483; 2011: one Form 483; 2016: one Form 483; 2019: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2004One Form 483, at Draper, Utah.
- 2011One Form 483, at Draper, Utah.
- 2011The longest 483 on file: 10 observations over 6 pages at Draper, Utah.
- 2016One Form 483, at Draper, Utah.
- 2019One Form 483, at Draper, Utah.
Cited most
Across all Wasatch Product Development observations on file
- 21 CFR 211.100Written procedures; deviations3
- 21 CFR 111.103What are the requirements under this subpart F for written procedures?1
- 21 CFR 211.103Calculation of yield1
- 21 CFR 211.125(a)Labeling issuance1
- 21 CFR 211.160(b)General requirements1
The complete Wasatch Product Development 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
Draper, Utah
Four Form 483s · 2004 to 2019 · 14 observations
Latest: Form 483, Apr 9, 2019 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2019-04-09 | 483 Form 483 | Draper, Utah | 1 | $99 |
| 2016-03-04 | 483 Form 483 | Draper, Utah | 2 | $99 |
| 2011-03-11 | 483 Form 483 | Draper, Utah | 10 | $99 |
| 2004-10-29 | 483 Form 483 | Draper, Utah | 1 | $99 |
Investigators on these documents
Caroline H. Le (1)Jamie L. Dion (1)Mew A. Jomean (1)Ricki A. Chase-Off (1)
FEI number 3003676119 · most recent document Apr 9, 2019
About Wasatch Product Development, LLC
How many FDA Form 483s has Wasatch Product Development, LLC received?
FDA Intel has 4 Form 483s on file for Wasatch Product Development, LLC; the most recent is dated Apr 9, 2019.
When was Wasatch Product Development, LLC last inspected by FDA?
The most recent FDA inspection document on file for Wasatch Product Development, LLC is a Form 483 dated Apr 9, 2019, for the site in Draper, Utah.
What did FDA cite at Wasatch Product Development, LLC?
The regulations cited most in the observations on file for Wasatch Product Development, LLC are 21 CFR 211.100 (Written procedures; deviations), 3 times; 21 CFR 111.103 (What are the requirements under this subpart F for written procedures?), 1 time; 21 CFR 211.103 (Calculation of yield), 1 time.