Rx Companies Push For Exemptions To Breadth Of FDA Inspections

Sterile areas, cell therapies, and security systems are just a few of the items where industry wants FDA inspector access limited without triggering a new law that would make products in a facility deemed adulterated.

Pharmaceutical industry stakeholders have picked apart FDA’s draft guidance on circumstances that constitute delaying, denying, limiting or refusing a drug inspection, asking the agency to allow companies to prevent or limit certain products or parts of a facility from inspection without the fear of triggering a FDA Safety and Innovation Act provision that would deem the drug adulterated.

Section 707 of FDASIA adds section 501(k) to the Food, Drug, and Cosmetic Act, deeming adulterated a drug that “has...

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