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Avoid These 5 Common Compliance Violations

Cover Image of Most Common Reasons for FDA Form 483 Observations and Warning Letters in Medical Device Environments Document
What's Included:

  • The most frequent FDA observations.

  • Establishing and maintaining proper CAPA procedures.

  • Processing customer complains.

  • Navigating extensive and complex supply chains.

About this Asset

FDA regulatory inspections are commonly followed by a list of objectionable conditions and compliance violations itemized in a Form 483 or warning letter. This industry brief will help you better understand the FDA's approach to regulation to easily identify and mitigate compliance issues.

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Improve Your Quality and Compliance Processes

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Avoid Lapses in CAPA Documentation

When companies don’t have documentation explaining why a CAPA wasn’t launched after a problem occurs, it raises a red flag with the FDA. Learn how using compliance audit software helps you effectively manage CAPA documentation and keep it audit-ready.

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Don’t Let Suppliers Undermine Compliance

Companies are often cited for failure to clearly define the type and extent of control to be exercised over suppliers. Find out how more efficient quality control in medical device manufacturing enables you to have more visibility and control over suppliers.

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Are There Gaps in Your Process Validation?

A common observation is when a validation procedure does not identify the frequency for validating and revalidating manufacturing processes. Find out how a risk-based approach to validation helps ensure compliance with this regulation.

Ensure Compliance Before an Audit

Find out how digitizing operations keeps you off the FDA’s mailing list.