Wasatch Product Development, LLC
Form 483 issued April 9, 2019 · Draper, Utah
- Inspection
- Apr 3 – Apr 9, 2019
- Investigator
- Mew A. Jomean
- Observations
- 1
- Pages
- 2
- FEI number
- 3003676119
In short: On April 9, 2019, FDA issued a Form 483 with 1 observation to Wasatch Product Development, LLC in Draper, Utah (FEI 3003676119) after an inspection that ran Apr 3 – Apr 9, 2019. The investigator was Mew A. Jomean. Most observations concern dietary supplement CGMP; the most-cited regulation is 21 CFR 111.103 (what are the requirements under this subpart F for written procedures?).
At a glance
1 of 1 observations on this 483 concern dietary supplement cgmp.
Most cited: 21 CFR 111.103 (1×)
What FDA observed
Preview: the opening words of each observation- 01
You did not establish and follow written procedures…
This inspection in context
Mew A. Jomean
1 document · 2019
Cites 111.103 (what are the requirements under this subpart f for written procedures?) more than any other section. Most of their documents are for sites in Utah.
The firmWasatch Product Development, LLC history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 111.103
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Wasatch Product Development, LLC?
FDA listed 1 observation on this Form 483, mostly about dietary supplement CGMP. The most-cited regulation is 21 CFR 111.103 (what are the requirements under this subpart F for written procedures?). The opening words of each observation are shown on this page.
Who inspected Wasatch Product Development, LLC?
Mew A. Jomean is named on this Form 483, for the inspection of Apr 3 – Apr 9, 2019. Each investigator has a profile showing what they cite most.
When was Wasatch Product Development, LLC inspected by FDA?
The inspection ran Apr 3 – Apr 9, 2019, and the Form 483 is dated April 9, 2019.
How do I get the full Form 483 for Wasatch Product Development, LLC?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.