Deseret Laboratories, Inc.
Form 483 issued November 18, 2022 · St. George, Utah
- Inspection
- Nov 14 – Nov 18, 2022
- Investigator
- Hung H. Do
- Observations
- 4
- Pages
- 6
- FEI number
- 1000160324
In short: On November 18, 2022, FDA issued a Form 483 with 4 observations to Deseret Laboratories, Inc. in St. George, Utah (FEI 1000160324) after an inspection that ran Nov 14 – Nov 18, 2022. The investigator was Hung H. Do. Most observations concern quality system and facilities & equipment.
At a glance
Quality system and facilities & equipment account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
Appropriate controls are not exercised over computers or related systems to assure that changes in taster…
- 02
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 03
Observation 3: scanned text, readable in the full document.
- 04
Drug product component testing is deficient in that at (b)(4) specific test to verify the identity…
This inspection in context
Hung H. Do
11 documents · 2021–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in California.
The firmDeseret Laboratories, Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.68(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Deseret Laboratories, Inc.?
FDA listed 4 observations on this Form 483, mostly about quality system, facilities & equipment and materials. The opening words of each observation are shown on this page.
Who inspected Deseret Laboratories, Inc.?
Hung H. Do is named on this Form 483, for the inspection of Nov 14 – Nov 18, 2022. Each investigator has a profile showing what they cite most.
When was Deseret Laboratories, Inc. inspected by FDA?
The inspection ran Nov 14 – Nov 18, 2022, and the Form 483 is dated November 18, 2022.
How do I get the full Form 483 for Deseret Laboratories, 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.