Western / Scott Fetzer Company
Form 483 issued August 12, 2016 · Westlake, Ohio
- Inspection
- Jul 11 – Aug 12, 2016
- Investigator
- Laureen M. Geniusz
- Observations
- 4
- Pages
- 5
- FEI number
- 1526809
In short: On August 12, 2016, FDA issued a Form 483 with 4 observations to Western / Scott Fetzer Company in Westlake, Ohio (FEI 1526809) after an inspection that ran Jul 11 – Aug 12, 2016. The investigator was Laureen M. Geniusz. Most observations concern cAPA and production & process controls.
At a glance
CAPA and production & process controls account for 4 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
Complaints involving the possible failure of a device to meet any of its specifications were…
- 02
Corrective and preventive action activities and/or results have…
- 04
Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements…
- 05
A process whose results cannot be fully verified by subsequent inspection and test has not been…
This inspection in context
Laureen M. Geniusz
10 documents · 2015–2026
Cites 820.30 (design controls) more than any other section. Most of their documents are for sites in Ohio.
The firmWestern / Scott Fetzer Company history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.198(c)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Western / Scott Fetzer Company?
FDA listed 4 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 Western / Scott Fetzer Company?
Laureen M. Geniusz is named on this Form 483, for the inspection of Jul 11 – Aug 12, 2016. Each investigator has a profile showing what they cite most.
When was Western / Scott Fetzer Company inspected by FDA?
The inspection ran Jul 11 – Aug 12, 2016, and the Form 483 is dated August 12, 2016.
How do I get the full Form 483 for Western / Scott Fetzer Company?
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.