Deseret Laboratories, Inc.
Form 483 issued March 23, 2018 · St. George, Utah
- Inspection
- Mar 19 – Mar 23, 2018
- Investigator
- Unary C. Penn
- Observations
- 4
- Pages
- 5
- FEI number
- 1000160324
In short: On March 23, 2018, FDA issued a Form 483 with 4 observations to Deseret Laboratories, Inc. in St. George, Utah (FEI 1000160324) after an inspection that ran Mar 19 – Mar 23, 2018. The investigator was Unary C. Penn. Most observations concern laboratory controls and facilities & equipment.
At a glance
Laboratory controls and facilities & equipment account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
Routine calibration of automatic, mechanical and electronic equipment is not performed according to a written program…
- 02
The master production and control records are deficient in that they do not include complete manufacturing…
- 03
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and standards designed…
- 04
Laboratory records do not include complete records of…
This inspection in context
Unary C. Penn
1 document · 2018
Cites 211.160(b) (general requirements) more than any other section. Most of their documents are for sites in Utah.
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(a)
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 laboratory controls, facilities & equipment and production. The opening words of each observation are shown on this page.
Who inspected Deseret Laboratories, Inc.?
Unary C. Penn is named on this Form 483, for the inspection of Mar 19 – Mar 23, 2018. Each investigator has a profile showing what they cite most.
When was Deseret Laboratories, Inc. inspected by FDA?
The inspection ran Mar 19 – Mar 23, 2018, and the Form 483 is dated March 23, 2018.
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.