Video: FDA Says Big Firms Meeting GMP Regs

In fiscal year 2014, large firms that have been inspected for GMPs have not recieved warning letters or injunctions, according to Cara welch, dietary supplement regulations implementations team lead, FDA’s Division of Dietary Supplement Programs.  

In fiscal year 2014, so far large firms (those with 500 employees or more) that have been inspected for GMPs (good manufacturing practices) have not had on official action indicated (OAI), which consists of a warning letter or injunction, according to Cara welch, dietary supplement regulations implementations team lead, FDA’s Division of Dietary Supplement Programs, who spoke to INSIDER at SupplySide West 2014. However, Welch noted that smaller and mid-sized firms have room for GMP improvement.

Watch this INSIDER interview to learn more about trends in GMP inspections, leadership changes at FDA and new Food Safety Modernization Act (FSMA) rules.

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