Wasatch Product Development, LLC
Form 483 issued October 29, 2004 · Draper, Utah
- Inspection
- Oct 25 – Oct 29, 2004
- Investigator
- Ricki A. Chase-Off
- Observations
- 1
- Pages
- 7
- FEI number
- 3003676119
In short: On October 29, 2004, FDA issued a Form 483 with 1 observation to Wasatch Product Development, LLC in Draper, Utah (FEI 3003676119) after an inspection that ran Oct 25 – Oct 29, 2004. The investigator was Ricki A. Chase-Off. Most observations concern production; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.100 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There are no written procedures for production and process controls designed to assure that the drug…
This inspection in context
Ricki A. Chase-Off
4 documents · 2002–2004
Cites 820.100 (corrective and preventive action) 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 211.100
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 production. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Wasatch Product Development, LLC?
Ricki A. Chase-Off is named on this Form 483, for the inspection of Oct 25 – Oct 29, 2004. Each investigator has a profile showing what they cite most.
When was Wasatch Product Development, LLC inspected by FDA?
The inspection ran Oct 25 – Oct 29, 2004, and the Form 483 is dated October 29, 2004.
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.