First Priority Incorporated
Form 483 issued November 18, 2021 · Elgin, Illinois
- Inspection
- Nov 8 – Nov 18, 2021
- Investigators
- Greg Brinsley· Nibin Varghese· Norman K. Starks
- Observations
- 7
- Pages
- 9
- FEI number
- 1000115137
In short: On November 18, 2021, FDA issued a Form 483 with 7 observations to First Priority Incorporated in Elgin, Illinois (FEI 1000115137) after an inspection that ran Nov 8 – Nov 18, 2021. The investigators were Greg Brinsley, Nibin Varghese and Norman K. Starks. Most observations concern facilities & equipment and quality system.
At a glance
Facilities & equipment and quality system account for 5 of 7 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures for the cleaning and maintenance of equipment are deficient regarding inspection of the equipment for…
- 02
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 03
The written stability testing…
- 04
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
This inspection in context
Greg Brinsley
1 document · 2021
Cites 211.166 (stability testing) more than any other section. Most of their documents are for sites in Illinois.
The firmFirst Priority Incorporated history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at First Priority Incorporated?
FDA listed 7 observations on this Form 483, mostly about facilities & equipment, quality system and laboratory controls. The opening words of each observation are shown on this page.
Who inspected First Priority Incorporated?
Greg Brinsley, Nibin Varghese and Norman K. Starks are named on this Form 483, for the inspection of Nov 8 – Nov 18, 2021. Each investigator has a profile showing what they cite most.
When was First Priority Incorporated inspected by FDA?
The inspection ran Nov 8 – Nov 18, 2021, and the Form 483 is dated November 18, 2021.
How do I get the full Form 483 for First Priority Incorporated?
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.