Poor records and poor management of good records can trigger needless costs, penalties, and public embarrassment for Food and Drug Administration-regulated companies. As if managing your own records isn’t challenging enough, FDA holds you equally responsible for ensuring the quality of records generated by your suppliers, contractors, and vendors.

To protect the integrity of your regulated products and your company’s reputation, you must be proactive and continuously monitor the activities and records of each link along your supply chain, including suppliers and vendors whose activities may affect the safety and efficacy of your final product. Even if FDA doesn’t directly regulate all of your suppliers, it’s ultimately your responsibility to ensure their records accurately reflect what’s happening at their sites.

What FDA expects from you
FDA expects you to have a good supplier/vendor management program that includes ongoing communication and management review. When the FDA comes calling, the agency wants you to be able to prove your vendors and suppliers are quality organizations who generate reliable records. For the kind of questions the FDA may ask about your suppliers see Table 1.

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