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FDA Inspectional and Regulatory Enforcement Trends: Key Focus on Trends in Consent Decree

Understand current Food and Drug Administration (FDA) regulatory guidance as well as current regulatory trends with regards to consent decree.<br>

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FDA Inspectional and Regulatory Enforcement Trends: Key Focus on Trends in Consent Decree

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Presentation Transcript

  1. Anticipating FDA Warning Letters?

  2. WHAT IS A WARNING LETTER? A Warning Letter is issued by the FDA to a regulated manufacturer if it is found that any significant regulatory violations have occurred.

  3. Violations Identified in Warning Letters Include- Nonconformance with Good Manufacturing Practices (GMP) False Claims About a Product Inadequate Training for Personnel Wrong directions for Use and so on…

  4. FDA Has Been Busy! (2000-2015) 4500+ Inspectors 130000+ 483S 170000+ Facilities 300000+ Inspections

  5. What Are The Trends?

  6. • Long standing internal problems that have not yet caught the attention of the FDA but are known within the company • Form 483 notifications (the most obvious predictor of Warning Letters) • Red flags from the Quality Unit • Adverse events • High volume of customer complaints • Prior investigations about the same issue or same type of issue • FDA responses to communications from the company that do not signal satisfaction with issue resolution and so on • Product contamination • Off-Label Promotional activities that have caught the attention of the FDA • DDMAC letters • Repeated FDA inspections of facilities Watch Out for Warning Letter Signs

  7. For more on FDA Compliance Visit our Website www.complianceonline FDA Compliance Thankyou !

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