PQ Corporation
Form 483 issued February 22, 2022 · Utica, Illinois
- Inspection
- Feb 15 – Feb 22, 2022
- Observations
- 6
- Pages
- 5
- FEI number
- 1421453
In short: On February 22, 2022, FDA issued a Form 483 with 6 observations to PQ Corporation in Utica, Illinois (FEI 1421453) after an inspection that ran Feb 15 – Feb 22, 2022. Most observations concern facilities & equipment and quality system.
At a glance
Observations span 4 systems, led by facilities & equipment.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Failure to have a quality unit that is independent of production and fulfills quality assurance (QA)…
- 02
Observation 2: scanned text, readable in the full document.
- 03
Failure to properly maintain buildings and facilities used in the manufacture of…
- 04
Failure to control the issuance of documents related to the manufacture of Active Pharmaceutical Ingredient (API)…
This inspection in context
Questions about this 483
What did FDA find at PQ Corporation?
FDA listed 6 observations on this Form 483, mostly about facilities & equipment, quality system and production. The opening words of each observation are shown on this page.
When was PQ Corporation inspected by FDA?
The inspection ran Feb 15 – Feb 22, 2022, and the Form 483 is dated February 22, 2022.
How do I get the full Form 483 for PQ Corporation?
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.