CDPH (California Department of Public Health) audit

sunnygreet

Starting to get Involved
Hello,
Does anyone know what does CDPH (California Department of Public Health) audit entails? I work for a medical device manufacturering company and we were just notified about CDPH audit as one of our supplier had a recall. No further details have been provided by our supplier nor CDPH except the audit dates. Please share any information.
 

Nichole F

Starting to get Involved
I've only experienced one audit with them at a previous job and it related to a transfer of company ownership. They did not provide dates ahead of time and showed up (unfortunately in the middle of our ISO/MDSAP audit). They just reviewed records relating to the company sale. I would imagine they are going to want to look at your records relating to the recall. The audit I experienced only took a few hours, thank goodness, as it was a very small team and handling auditors from two separate organizations was a challenge!
 

yodon

Leader
Super Moderator
I've had a couple of clients in Texas who have been inspected by Texas Department of Health, acting for the FDA (routine inspection). Not sure if this is your case, of course.

But you're ready for anything, right? :)
 
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