First Priority Incorporated
Form 483 issued July 30, 2024 · Elgin, Illinois
- Inspection
- Jul 22 – Jul 30, 2024
- Investigator
- Nibin Varghese
- Observations
- 6
- Pages
- 7
- FEI number
- 1000115137
In short: On July 30, 2024, FDA issued a Form 483 with 6 observations to First Priority Incorporated in Elgin, Illinois (FEI 1000115137) after an inspection that ran Jul 22 – Jul 30, 2024. The investigator was Nibin Varghese. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
4 of 6 observations on this 483 concern quality system.
Most cited: 21 CFR 211.22 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The quality control unit lacks the responsibility and authority to approve and reject all components, closures…
- 02
The responsibilities and procedures applicable to the quality control unit are not in…
- 03
Complaint records are deficient in that they do not include the…
- 04
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
This inspection in context
Nibin Varghese
14 documents · 2021–2026
Cites 211.22 (responsibilities of quality control unit) 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 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at First Priority Incorporated?
FDA listed 6 observations on this Form 483, mostly about quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected First Priority Incorporated?
Nibin Varghese is named on this Form 483, for the inspection of Jul 22 – Jul 30, 2024. Each investigator has a profile showing what they cite most.
When was First Priority Incorporated inspected by FDA?
The inspection ran Jul 22 – Jul 30, 2024, and the Form 483 is dated July 30, 2024.
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.