Stronger Drug Safety: Unannounced Inspections of Foreign Facilities.
This law strengthens the FDA's authority to conduct unannounced inspections of foreign facilities that manufacture drugs for the US market. The goal is to enhance the safety and quality of imported pharmaceuticals, directly impacting public health. Implementing surprise inspections prevents manufacturers from concealing potential safety issues.
Key points
The FDA is now required to conduct unannounced inspections of foreign drug manufacturing sites, unless mandated by local law or necessary for public health protection.
If a foreign country mandates advance notice, the manufacturer must waive this right or face penalties for refusing inspection.
This change aims to improve the quality and safety of medications available to American consumers.
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