USANA Health Sciences, Inc.
Form 483 issued March 18, 2022 · Salt Lake City, Utah
- Inspection
- Mar 14 – Mar 18, 2022
- Investigators
- Carolina D. Vasquez· Crystal Monroy
- Observations
- 2
- Pages
- 3
- FEI number
- 1720505
In short: On March 18, 2022, FDA issued a Form 483 with 2 observations to USANA Health Sciences, Inc. in Salt Lake City, Utah (FEI 1720505) after an inspection that ran Mar 14 – Mar 18, 2022. The investigators were Carolina D. Vasquez and Crystal Monroy. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.166 (stability testing).
At a glance
Laboratory controls and quality system account for 2 of 2 observations.
Most cited: 21 CFR 211.166(a) (1×) · 211.198(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
There is no written testing program designed to assess the stability…
- 02
Procedures describing the handling of written and oral complaints related to drug products are…
This inspection in context
Carolina D. Vasquez
9 documents · 2022–2026
Cites 211.166 (stability testing) more than any other section. Most of their documents are for sites in California.
The firmUSANA Health Sciences, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.166(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at USANA Health Sciences, Inc.?
FDA listed 2 observations on this Form 483, mostly about laboratory controls and quality system. The most-cited regulation is 21 CFR 211.166 (stability testing). The opening words of each observation are shown on this page.
Who inspected USANA Health Sciences, Inc.?
Carolina D. Vasquez and Crystal Monroy are named on this Form 483, for the inspection of Mar 14 – Mar 18, 2022. Each investigator has a profile showing what they cite most.
When was USANA Health Sciences, Inc. inspected by FDA?
The inspection ran Mar 14 – Mar 18, 2022, and the Form 483 is dated March 18, 2022.
How do I get the full Form 483 for USANA Health Sciences, Inc.?
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.