Monday, August 5, 2013

Veteran FDA Inspector Answers Questions for FDAzilla's 483 Month

Altruistic FDA inspector explains his perspective at this Q&A post:

FDAzilla asks questions of a veteran FDA auditor

What's very interesting is that there is an open admission to the "tremendous amount of [inspector-to-inspector] variability" when queried on level of scrutiny as well as US vs. ex-US inspections.

How is a federal agency supposed to enforce a uniform code with "tremendous variability"?

My grapevine tells me that the same manufacturing plant... running with essentially the same management, the same people, and the same underlying issues will face different scrutiny just because their plant got sold to another company.

It's just strange that someone can think how "tremendous variability" in inspections and auditing comports with an "agency [who is] mission-driven to stop adulterated product from distribution."

Read the original story here.

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