Foreign Supplier Verification Program: Who Needs One?

Foreign Supplier Verification Program: Who Needs One?

FDA issued the final rule for the Foreign Supplier Verification Program (FSVP) last week. This final rule is the first step in implementing the Food Safety Modernization Act’s (FSMA’s) mandate that U.S. importers verify their foreign manufacturers’ compliance with...

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Labeling For Medical Products Not Made With Natural Rubber Latex

Some manufacturers label or promote their products as “latex free” or “does not contain latex” to inform users that natural rubber latex in any of its forms was not used in their product. In a guidance document titled "Recommendations for Labeling Medical Products to...

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Renewal Season Starts October 1 – Are You Ready?

Between October 1 and December 31 every year, FDA-registered facilities around the world must submit renewals to their registrations (except registered food facilities, which must renew every even-numbered year).   If your facility is registered with FDA, then this...

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Still Waiting: FDA Not Yet Published the HARPC Final Rule

This week the Food and Drug Administration (FDA) was required to submit the final rule for the Hazard Analysis and Risk-Based Preventive Controls (HARPC) for publication in the Federal Register. According to FDA, this was completed on August 31, but curiously FDA has...

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5 Things You Should Know About Import Alerts

5 Things You Should Know About Import Alerts

Don’t Wait to Act Until FDA Adds the Company to Import Alert Waiting until you get red-listed before identifying what happened and fixing it is a big time-and-money mistake. However, if you wait until your company is added to an import alert, you will likely have a...

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Special Cases for UDI Requirements

Special Cases for UDI Requirements

Multiple-Use Devices Devices intended for multiple use, and intended to be reprocessed before each use, will likely have their original packaging discarded when the device is first used.  Therefore, these devices must bear a Unique Device Identifier (UDI) as a...

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