March 19th, 2013 // 3:43 pm @ jmpickett
March 18, 2013
Our recent Webinar speaker, Dennis Moore, AUK Technical Services, noted that while having your production system down during an inspection is not necessary, it can be useful in some situations.
On the ‘no’ side, Moore noted that most 483 hits come on records review, not during production. So, in that sense, having production down is not needed and may not be necessary.
However, on the ‘yes’ side, if you have your production up, they are going to pull your training records. So, there is a tangible benefit to having your production down – you can have workers on furlough so that the investigator can’t ask them probing questions.
Of course, they’re going to pull your training records no matter what. But if the actual people are not there, it tends to make your inspection go a bit easier on the training side.
If you enjoyed this FDA inspection tip, take a look at Dennis Moore’s repeat Webinar on April 11 – How the Quality Manager Gets Fired, the $100,000 Compliance SNAFU, And 21 Tips and Tricks For Your Next Audit.
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