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