Wasatch Product Development, LLC
Form 483 issued March 4, 2016 · Draper, Utah
- Inspection
- Feb 29 – Mar 4, 2016
- Investigator
- Jamie L. Dion
- Observations
- 2
- Pages
- 4
- FEI number
- 3003676119
In short: On March 4, 2016, FDA issued a Form 483 with 2 observations to Wasatch Product Development, LLC in Draper, Utah (FEI 3003676119) after an inspection that ran Feb 29 – Mar 4, 2016. The investigator was Jamie L. Dion. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Quality system and production account for 2 of 2 observations.
Most cited: 21 CFR 211.22(d) (1×) · 211.103 (1×)
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
Actual yield and percentages of theoretical yield are not determined at the conclusion of each appropriate…
This inspection in context
Jamie L. Dion
11 documents · 2013–2019
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Colorado.
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 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Wasatch Product Development, LLC?
FDA listed 2 observations on this Form 483, mostly about quality system and production. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Wasatch Product Development, LLC?
Jamie L. Dion is named on this Form 483, for the inspection of Feb 29 – Mar 4, 2016. Each investigator has a profile showing what they cite most.
When was Wasatch Product Development, LLC inspected by FDA?
The inspection ran Feb 29 – Mar 4, 2016, and the Form 483 is dated March 4, 2016.
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.