Sharing Troy Fugate's LinkedIN posting..
FDA 483 observations require serious, well-documented corrective actions, but some companies have responded with unbelievable excuses, inadequate justifications, or outright bizarre explanations. Here are some of the craziest real-life 483 responses seen in the pharmaceutical and biotech industries.
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1. "We Fired the Employee, So the Problem No Longer Exists"
FDA Observation: Operators were repeatedly failing to follow aseptic gowning procedures.
Company’s Response:
“We have terminated the employee responsible for...
