Ferno-Washington Inc
Form 483 issued January 24, 2023 · Wilmington, Ohio
- Inspection
- Jan 9 – Jan 24, 2023
- Investigator
- Rosanna M. Goodrich
- Observations
- 6
- Pages
- 7
- FEI number
- 1523574
In short: On January 24, 2023, FDA issued a Form 483 with 6 observations to Ferno-Washington Inc in Wilmington, Ohio (FEI 1523574) after an inspection that ran Jan 9 – Jan 24, 2023. The investigator was Rosanna M. Goodrich. 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
Procedures for collective and preventive action have…
- 02
A process whose results cannot be fully verified by subsequent inspection and test has not been…
- 03
Requirements that must be met by suppliers and contractors have…
- 04
Complaints involving the possible failure of a device to meet any of its specifications were…
This inspection in context
Rosanna M. Goodrich
13 documents · 2015–2025
Cites 820.100(a) (corrective and preventive action) more than any other section. Most of their documents are for sites in Ohio.
The firmFerno-Washington Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Ferno-Washington 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 Ferno-Washington Inc?
Rosanna M. Goodrich is named on this Form 483, for the inspection of Jan 9 – Jan 24, 2023. Each investigator has a profile showing what they cite most.
When was Ferno-Washington Inc inspected by FDA?
The inspection ran Jan 9 – Jan 24, 2023, and the Form 483 is dated January 24, 2023.
How do I get the full Form 483 for Ferno-Washington 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.