New Year, Same Challenges: Pharma's Ongoing Struggle with FDA 483s
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All pharmaceutical or medical device companies with products destined for the United States (US) market, operate under strict manufacturing practices to ensure public safety, efficacy, and consistent product quality. The US Food and Drug Administration (FDA) plays a pivotal role in this oversight through the employment of Good Manufacturing Practices (GMPs).
Despite intensive internal controls and monitoring systems, these industries frequently receive FDA Form 483s – inspectional observations – and in the most serious cases, a warning letter. This SIA/LBG paper examines inspection findings most commonly related to documentation practices and procedures including SOPs, incomplete or inadequate deviations and non-conformances and outlines strategies to address and prevent regulatory non-compliance.
