How to Pass FDA Factory Inspections

Topics:
Healthcare Products
Tags:
Factory Inspection,
FDA,
Federal Government,
Government
Source:
Business Briefings

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Overview: "Be prepared" is the best advice one can give. Those executives who have suffered an import ban following a factory inspection by the US Food and Drug Administration (FDA) know the value of this advice. Despite this obvious statement, many medical device companies do not spend enough time developing their systems to ensure compliance with all aspects of Current Good Manufacturing Practices. This article provides insights into where to start, what guidance is available, pre-inspection preparation and managing the inspection and offers suggestions for a procedure/plan for FDA factory inspections.

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Format: PDF | Size: 620KB | Date: Jul 2004 | Pages: 4

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