Commercial Plastics Kenosha LLC
Form 483 issued November 7, 2024 · Kenosha, Wisconsin
- Inspection
- Nov 4 – Nov 7, 2024
- Investigators
- Chad E. Schmear· Nicholas Z. Lu
- Observations
- 5
- Pages
- 5
- FEI number
- 3007617202
In short: On November 7, 2024, FDA issued a Form 483 with 5 observations to Commercial Plastics Kenosha LLC in Kenosha, Wisconsin (FEI 3007617202) after an inspection that ran Nov 4 – Nov 7, 2024. The investigators were Chad E. Schmear and Nicholas Z. Lu. Most observations concern production & process controls and cAPA.
At a glance
3 of 5 observations on this 483 concern production & process controls.
What FDA observed
Preview: the opening words of each observation- 01
Process validation activities have…
- 02
Procedures have not been adequately established to control product that does not…
- 03
Software used as pail of production and the quality system has not been adequately validated for…
- 04
Procedures for training and identifying training needs have…
This inspection in context
Chad E. Schmear
4 documents · 2002–2026
Cites ISO 13485:2016 Clause 8.3.1 more than any other section. Most of their documents are for sites in Wisconsin.
The firmCommercial Plastics Kenosha LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.75(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Commercial Plastics Kenosha LLC?
FDA listed 5 observations on this Form 483, mostly about production & process controls, cAPA and management controls. The opening words of each observation are shown on this page.
Who inspected Commercial Plastics Kenosha LLC?
Chad E. Schmear and Nicholas Z. Lu are named on this Form 483, for the inspection of Nov 4 – Nov 7, 2024. Each investigator has a profile showing what they cite most.
When was Commercial Plastics Kenosha LLC inspected by FDA?
The inspection ran Nov 4 – Nov 7, 2024, and the Form 483 is dated November 7, 2024.
How do I get the full Form 483 for Commercial Plastics Kenosha LLC?
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.