Molder Rubber and Plastic Corporation
Form 483 issued December 16, 2024 · Butler, Wisconsin
- Inspection
- Dec 10 – Dec 16, 2024
- Investigator
- Chad E. Schmear
- Observations
- 4
- Pages
- 6
- FEI number
- 3015239144
In short: On December 16, 2024, FDA issued a Form 483 with 4 observations to Molder Rubber and Plastic Corporation in Butler, Wisconsin (FEI 3015239144) after an inspection that ran Dec 10 – Dec 16, 2024. The investigator was Chad E. Schmear. Most observations concern production & process controls and cAPA.
At a glance
Production & process controls and capa account for 4 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
A process whose results cannot be fully verified by subsequent inspection and test has not been…
- 02
Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements…
- 03
Procedures for collective and preventive action have…
- 04
Procedures have not been adequately established to control product that does not…
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 firmMolder Rubber and Plastic Corporation 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 Molder Rubber and Plastic Corporation?
FDA listed 4 observations on this Form 483, mostly about production & process controls and cAPA. The opening words of each observation are shown on this page.
Who inspected Molder Rubber and Plastic Corporation?
Chad E. Schmear is named on this Form 483, for the inspection of Dec 10 – Dec 16, 2024. Each investigator has a profile showing what they cite most.
When was Molder Rubber and Plastic Corporation inspected by FDA?
The inspection ran Dec 10 – Dec 16, 2024, and the Form 483 is dated December 16, 2024.
How do I get the full Form 483 for Molder Rubber and Plastic 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.