The Ohio WillowWood Company
Form 483 issued January 22, 2016 · Mount Sterling, Ohio
- Inspection
- Nov 20, 2015 – Jan 22, 2016
- Investigator
- Rosanna M. Goodrich
- Observations
- 9
- Pages
- 6
- FEI number
- 1522166
In short: On January 22, 2016, FDA issued a Form 483 with 9 observations to The Ohio WillowWood Company in Mount Sterling, Ohio (FEI 1522166) after an inspection that ran Nov 20, 2015 – Jan 22, 2016. The investigator was Rosanna M. Goodrich. Most observations concern cAPA and production & process controls; the most-cited regulation is 21 CFR 820.90 (nonconforming product).
At a glance
CAPA and production & process controls account for 6 of 9 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for corrective and preventive action have…
- 02
Production processes were not controlled and monitored to ensure that a device…
- 03
A process whose results cannot be fully verified by subsequent inspection and test has not been…
- 04
Procedures for rework of nonconforming product have…
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 firmThe Ohio WillowWood Company 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 The Ohio WillowWood Company?
FDA listed 9 observations on this Form 483, mostly about cAPA, production & process controls and records & documents. The most-cited regulation is 21 CFR 820.90 (nonconforming product). The opening words of each observation are shown on this page.
Who inspected The Ohio WillowWood Company?
Rosanna M. Goodrich is named on this Form 483, for the inspection of Nov 20, 2015 – Jan 22, 2016. Each investigator has a profile showing what they cite most.
When was The Ohio WillowWood Company inspected by FDA?
The inspection ran Nov 20, 2015 – Jan 22, 2016, and the Form 483 is dated January 22, 2016.
How do I get the full Form 483 for The Ohio WillowWood Company?
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