Wasatch Product Development, LLC
Form 483 issued March 11, 2011 · Draper, Utah
- Inspection
- Mar 7 – Mar 11, 2011
- Investigator
- Caroline H. Le
- Observations
- 10
- Pages
- 6
- FEI number
- 3003676119
In short: On March 11, 2011, FDA issued a Form 483 with 10 observations to Wasatch Product Development, LLC in Draper, Utah (FEI 3003676119) after an inspection that ran Mar 7 – Mar 11, 2011. The investigator was Caroline H. Le. Most observations concern production and materials; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Observations span 4 systems, led by production.
What FDA observed
Preview: the opening words of each observation- 01
There are no written procedures for production and process controls designed to assure that the drug…
- 02
Batch production and control records do not include complete information relating to the production and…
- 03
Written records are not always made of investigations into unexplained discrepancies and the failure of a…
- 04
Each component is not tested for conformity with all appropriate written specifications for purity…
This inspection in context
Caroline H. Le
6 documents · 2008–2011
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Michigan.
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(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Wasatch Product Development, LLC?
FDA listed 10 observations on this Form 483, mostly about production, materials and facilities & equipment. 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?
Caroline H. Le is named on this Form 483, for the inspection of Mar 7 – Mar 11, 2011. Each investigator has a profile showing what they cite most.
When was Wasatch Product Development, LLC inspected by FDA?
The inspection ran Mar 7 – Mar 11, 2011, and the Form 483 is dated March 11, 2011.
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.