Polyconversions, Inc
Form 483 issued August 7, 2019 · Champaign, Illinois
- Inspection
- Aug 6 – Aug 7, 2019
- Investigator
- Shafiq S. Ahadi
- Observations
- 6
- Pages
- 5
- FEI number
- 3001239227
In short: On August 7, 2019, FDA issued a Form 483 with 6 observations to Polyconversions, Inc in Champaign, Illinois (FEI 3001239227) after an inspection that ran Aug 6 – Aug 7, 2019. The investigator was Shafiq S. Ahadi. Most observations concern cAPA and production & process controls.
At a glance
CAPA and production & process controls account for 6 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
Written MDR procedures have not been…
- 02
Procedures for corrective and preventive action…
- 03
A process whose results cannot be fully verified by subsequent inspection and test has not been…
- 04
Procedures for acceptance of incoming product…
This inspection in context
Shafiq S. Ahadi
7 documents · 2016–2025
Cites 820.30(b) (design controls) more than any other section. Most of their documents are for sites in Illinois.
The firmPolyconversions, Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 803.17
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Polyconversions, Inc?
FDA listed 6 observations on this Form 483, mostly about cAPA and production & process controls. The opening words of each observation are shown on this page.
Who inspected Polyconversions, Inc?
Shafiq S. Ahadi is named on this Form 483, for the inspection of Aug 6 – Aug 7, 2019. Each investigator has a profile showing what they cite most.
When was Polyconversions, Inc inspected by FDA?
The inspection ran Aug 6 – Aug 7, 2019, and the Form 483 is dated August 7, 2019.
How do I get the full Form 483 for Polyconversions, 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.