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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 new policy requiring employees to follow existing policies.”
Why It’s Ridiculous:
• A policy that tells people to follow policies does not fix procedural noncompliance.
• The FDA expects effective training, enforcement, and quality oversight, not redundant documentation.
• This response shows no corrective action to address why procedures were ignored in the first place.
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3. “The Rodents Were Only in the Warehouse, Not in the Production Area”
FDA Observation: Live rodents were observed in the facility, including near raw materials.
Company’s Response:
“The rodents were only seen in the warehouse and did not enter the production areas, so product quality was not impacted.”
Why It’s Ridiculous:
• The presence of rodents in any part of a GMP facility is a major red flag.
• This response fails to acknowledge the contamination risk posed by rodents.
• The FDA expects pest control programs, root cause analysis, and preventive measures, not downplaying the issue.
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4. “The Missing Data is Not Important Anyway”
FDA Observation: Data integrity violations were found, including deleted batch records.
Company’s Response:
“The missing data does not impact product safety or efficacy.”
Why It’s Ridiculous:
• Any missing or deleted data is an automatic data integrity red flag.
• The FDA requires full traceability in manufacturing records.
• This response shows a complete misunderstanding of cGMP compliance.
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5. “We Didn’t Know We Had to Do That”
FDA Observation: The company failed to test incoming raw materials for identity, purity, and potency.
Company’s Response:
“We were not aware that testing was required before using raw materials in production.”
Why It’s Ridiculous:
• Raw material testing is a fundamental GMP requirement.
• Ignorance of regulations is never an acceptable excuse.
• The FDA expects comprehensive training and regulatory awareness in any manufacturing facility.
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6. “We Are Working on Fixing the Issue, But We Have No Timeline”
FDA Observation: The company failed to implement corrective actions for previously cited issues.
Company’s Response:
“We are actively working on addressing this concern but do not have a specific timeline for completion.”
Why It’s Ridiculous:
• The FDA expects clear corrective action plans with defined timelines.
• “Working on it” without a deadline suggests a lack of urgency and commitment.
• Failure to resolve compliance issues in a timely manner can result in warning letters, consent decrees, or product recalls.
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7. “We Have Been Doing It This Way for Years and Never Had a Problem”
FDA Observation: The company failed to validate its sterilization process for injectable drugs.
Company’s Response:
“We have used this process for 10 years without any sterility issues.”
Why It’s Ridiculous:
• Past success does not justify noncompliance with validation requirements.
• GMP regulations require scientifically justified validation, not just historical assumptions.
• The FDA does not accept the argument of “we’ve always done it this way.”
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8. “We Will Conduct Training, But We Don’t Think It’s Necessary”
FDA Observation: Employees were not trained in GMP procedures for sterile drug manufacturing.
Company’s Response:
“We will conduct additional training, even though we do not believe it is necessary.”
Why It’s Ridiculous:
• If the FDA identifies a training deficiency, it is necessary.
• This response shows a lack of commitment to compliance.
• The FDA expects proactive training programs, not reluctance to educate staff.
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9. “It’s Not a Big Deal Because We Fixed It After the FDA Found It”
FDA Observation: Cleaning validation was inadequate, leading to cross-contamination risks.
Company’s Response:
“The issue was fixed immediately after the FDA inspection, so it is no longer a concern.”
Why It’s Ridiculous:
• Compliance should be continuous, not just when inspectors are watching.
• The FDA expects preventive controls and quality oversight, not reactive fixes.
• This response suggests the company only addresses problems when caught, which is a huge regulatory risk.
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10. “We Don’t Have a CAPA Plan, But We Will Try Not to Let It Happen Again”
FDA Observation: A repeated deviation was found in multiple batches.
Company’s Response:
“We do not have a formal corrective action plan but will make efforts to avoid this issue in the future.”
Why It’s Ridiculous:
• The FDA requires a Corrective and Preventive Action (CAPA) plan to address systemic failures.
• “Trying harder” is not an acceptable compliance strategy.
• The response must include a detailed action plan, accountability measures, and preventive controls.
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Final Thoughts: How to Avoid a Bad 483 Response
If your company receives a 483 observation, follow these principles for a strong response:
- Acknowledge the issue and take responsibility.
- Provide a clear corrective action plan with timelines.
- Demonstrate root cause analysis and preventive measures.
- Show commitment to continuous compliance.
- Avoid excuses, blame-shifting, or vague promises.
The FDA expects substance, not spin—a well-prepared response can mean the difference between a smooth resolution and an escalation to a warning letter.
Would you like a template for an FDA 483 response that meets regulatory expectations?
Website: www.compliance-insight.com
Email: info@compliance-insight.com
Phone: 513-860-3512