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 these violations. Therefore, this issue has been resolved.”
Why It’s Ridiculous:
• Systemic failures cannot be fixed by firing a single employee.
• The FDA expects root cause analysis and corrective actions, not a scapegoat approach.
• The problem likely extends beyond one person to poor training, lack of oversight, and inadequate SOP enforcement.
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2. "We Will Implement a Policy to Follow Our Policies"
FDA Observation: The company failed to follow its own written procedures for batch release.
Company’s Response:
“To correct this issue, we will create a ...
