by Martin Browning, President, EduQuest, Inc.
FDA expert investigator and rule-maker for 22 yearsAlthough FDA is strapped with limited resources and competing priorities, the Agency continues to hammer regulated companies with FDA 483 inspection observations and Warning Letters.
In 2014 alone, FDA conducted more than 38,000 inspections and issued 8,457 Form 483s -- inspection observations that, in the inspector’s judgment, indicated an operation or product violated FDA requirements.
To maintain this enforcement pace while replacing an aging workforce, FDA has hired a number of new inspectors. Although some “veterans” remain, it’s highly possible your next inspection will be conducted by one of the Agency’s less experienced investigators.
Lacking industry-specific knowledge, new inspectors are less likely to understand and accept your explanation of unfamiliar products or processes. So if you find yourself in a situation where you disagree with a 483 observation, you need to know how to respond effectively and responsibly to keep a minor dispute from escalating to a major legal battle.
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