CO-AX Technology Inc
Form 483 issued August 2, 2023 · Solon, Ohio
- Inspection
- Jul 24 – Aug 2, 2023
- Investigators
- Benjamin Dastoli· Melina L. Rodriguez-Upton
- Observations
- 9
- Pages
- 8
- FEI number
- 3013413442
In short: On August 2, 2023, FDA issued a Form 483 with 9 observations to CO-AX Technology Inc in Solon, Ohio (FEI 3013413442) after an inspection that ran Jul 24 – Aug 2, 2023. The investigators were Benjamin Dastoli and Melina L. Rodriguez-Upton. Most observations concern production & process controls and cAPA; the most-cited regulation is 21 CFR 820.90 (nonconforming product).
At a glance
Production & process controls and capa account for 9 of 9 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 for rework of nonconforming product…
- 03
Procedures to ensure equipment is routinely calibrated have…
- 04
Procedures for acceptance of incoming product have…
This inspection in context
Benjamin Dastoli
12 documents · 2009–2023
Cites 820.75 (process validation) more than any other section. Most of their documents are for sites in Ohio.
The firmCO-AX Technology Inc 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 CO-AX Technology Inc?
FDA listed 9 observations on this Form 483, mostly about production & process controls and cAPA. The most-cited regulation is 21 CFR 820.90 (nonconforming product). The opening words of each observation are shown on this page.
Who inspected CO-AX Technology Inc?
Benjamin Dastoli and Melina L. Rodriguez-Upton are named on this Form 483, for the inspection of Jul 24 – Aug 2, 2023. Each investigator has a profile showing what they cite most.
When was CO-AX Technology Inc inspected by FDA?
The inspection ran Jul 24 – Aug 2, 2023, and the Form 483 is dated August 2, 2023.
How do I get the full Form 483 for CO-AX Technology Inc?
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