Quality control rejected

The FDA red-list, what’s that?

Posted on October 29, 2013 · Posted in Medical Device Manufacturing

Do you know for sure that your medical materials and parts suppliers are meeting FDA quality system regulations?

One of the most common reasons medical manufactures are presented with 483s by the FDA or imported medical parts are held at customs are due to cGMP violations.

There are simple ways to assure your suppliers and sub-suppliers are meeting these cGMP requirements.

1. Build up a Certificate of Conformity program with your suppliers and their sub-suppliers.
This means setting up approval and sign off processes for acceptable materials and parts from your suppliers. Each manufacturing run should identify the precise specifications to be met. This way, you know your contract manufacturing team is inspecting and verifying that all materials meet your manufacturing needs. (Identifying these specifications in your POs and DMR’s will help with this) Once any part or material does not meet precise specifications, your suppliers should have a process in place to make sure these materials are quarantined.

2. Perform regular audits on your suppliers. At least once a year, request to see verification, validation and SOP documents that relate to your manufactured product. You can ask to see documented evidence that these processes are being followed. Take the time to visit your suppliers and sub-suppliers. This allows you to keep current on the status of the production environment and the status of machinery.

3. Regularly check the FDA import red-list to assure your foreign partners have not been placed on an import “hold” list. The red-list identifies off-shore suppliers that have been known to manufacture goods that do not meet certain safety standards, meet cGMP documentation standards or have tried to import goods that were not registered, cleared or approved of by the FDA.
Some cGMP violators can be seen here.

Contact Guideline Medical if you need help managing your medical device suppliers and manufacturing compliance issues. Our team of experts will help guide you through the process.

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