Regulatory Focus™ > News Articles > Warning Letter Analysis: FDA Cracks Down on Companies With Unregistered Facilities

Warning Letter Analysis: FDA Cracks Down on Companies With Unregistered Facilities

Posted 06 June 2012 | By

The US Food and Drug Administration (FDA) sent eight warning letters to foreign-based pharmaceutical manufacturers between January 2012 and May 2012 after finding the companies were exporting pharmaceutical products to the US in violation of the Federal Food, Drug and Cosmetic Act.

Specifically, the primarily Asian-based companies has failed to register their facilities with FDA, which requires the registrations to exercise oversight over the facilities' manufacturing practices through inspections and monitoring.

In nearly identical letters sent to the eight companies, FDA said it was made aware of the infractions after it "reviewed entries regarding shipments of drugs into the US from the establishment listed above, as well as information on file concerning [the companies'] establishment drug registration and listing."

All of the companies were at one time registered, noted FDA, but none of the companies had taken the "opportunity to register" after being informed of their soon-to-be-lapsed registrations. Facility registration is required of companies exporting products to the US on a yearly basis.

The eight companies informed of the registration violations are:


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