Outgoing FDA Inspector Advises Patience with New Faces

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Michael Causey
In FDA Regulated Industries

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

After 12 years and some 300 inspections Patrick Stone, outgoing Consumer Safety Officer and Investigator at the FDA’s Austin office, says the large influx of new inspectors is going to take some time to come up to speed. Most inspectors need about five years of training before they have a solid foundation, Stone says.

His advice for medical device companies and others who face FDA inspections from one of the Young Guns? “Patience.”

As we’ve blogged before, the FDA has suffered from something of a brain drain in the past several years, where some of the more experienced personnel left for greener pastures because they were tired of budget cuts, politics and other issues many felt hampered the agency’s ability to do its job of protecting the public while encouraging innovation. Stone, who left the agency March 25, estimated he’d helped hire and train about 200 new employees in his Texas, Oklahoma and Arkansas territory over the past several years.

Stone says it’s not particularly wise to ask your inspector how much experience they have, but it’s basic common sense that “if they are young and fresh-faced, they probably don’t have much yet,” he advises. In those cases, it behooves you to gently educate them without getting condescending about it.

He says these inspectors will focus like laser beams on any changes in your procedures, even ones you genuinely believe are unimportant. “They want to see changes and failures, to see what went wrong and how you investigated it,” Stone says.

“Be proactive with the agency” in this area, he advises, and you’ll earn a lot of street cred. “Account for changes beforehand even if they are seemingly benign.” The new crop of inspectors is particularly focused on “transparency,” and if they feel you are being open with them, you’re chances of having a relatively smooth inspection are a lot better, Stone says.

Stone has specialized in IRB compliance & QA audits and cell & gene therapy development and implementation, and helped many IRB’s and gene therapy labs comply with FDA regulations, 21 CFR, GCP, & ICH compliance. He’s setting up his own independent consulting shop in the coming weeks.

Stone also applauded the FDA’s recent efforts to centralize more of its operations in its White Oak, MD headquarters. It will take some time, but he believes that effort will eventually make the inspection process more uniform nationwide. “It will help them to be on the same page” with inspections, and that will be helpful to regulated companies who have complained of inconsistency in the past.

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    is it a normal that an inspector shows up at noon in a restaurant or bakery , right in the middle of the rush?
    Ist it normal that an inspector finding a non critical violation who is corrected immediatly in front him, because he did not look properly, than he will still right it down on his report ?

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