California FDB (Food & Drug Branch) inspection experiences?

V

victoriab65

#1
It's been awhile since I have been through a California Food & Drug Branch inspection. I was wondering if fellow Californians could briefly share any insights about recent FDB inspections with regard to the focus of inspections and documents reviewed, amount of time spent in the facility, if QSIT approach was used, etc.

Thanks in advance,

-Victoria
 
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W

Watchwait

#3
Hi Victoria,

I have entertained auditors from CA Food & Drug Branch on multiple occasions. In short, there is no "pattern". I have hosted audits that lasted 1 day - and audits that have lasted 4 days. A couple things to keep in mind:

* The workload for CA F & D auditors is now very high. This, and the fact that the state has a plethora of budget issues stretches and already short resource even further. Consequently, it is next to impossible to determine when your organization might be scheduled for an audit.

* The QSIT approach, while a good model, is as often as not ignored. Doesn't mean it can't take that form - just be prepared for the more conventional "let's start with the complaint files" approach and go from there.

* Again, due to staffing limitations, the state investigators typically service a wide range of industries. This means that your investigator may have spent most of his/her time at a fish processing, tomato packaging of eto sterilization facility before coming to your plant. Again, not a travesty, but it does mean extra effort on your behalf in accelerating the learning curve as it relates to your systems and products.

* Also, the biggest difference between the State of CA F & D and the US FDA is that an initial State inspection of your facility is MANDATORY before you can manufacture medical devices at a facility in CA. Not an issue if you have already been inspected, but if this is your 1st facility inspection be sure to submit your facility registration as early as possible in the process. It's not unusual for 3-4 months to elapse from submission of your facility registration until an inspection is actually scheduled.

Good luck!
Steve
 
N

nahrat

#4
FYI.
A bit of information that isn't well known to companies in California:
In the event that you've recently gone through an FDA QSIT inspection, notify your CA FDB investigator before they visit your site. Based on the details involved in the FDA inspection, the CA investigator may choose to waive their inspection (to prevent duplicate efforts). However, they may also decide to proceed with the visit. It's the auditor's prerogative.

-Tarhan
 
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