The FDA Let Substandard Factor... Note
ProPublica

The FDA Let Substandard Factories Ship These Medications to the U.S.

The FDA has been allowing substandard foreign factories, previously banned for manufacturing failures, to continue shipping medications to the U.S. ProPublica revealed this practice, noting the FDA's justification was to prevent drug shortages and that exemptions included extra testing by banned factories. However, the FDA itself did not regularly test these drugs or actively monitor adverse event reports from consumers and doctors. Drug safety experts caution that without further study, the impact of these drugs on public health remains unknown. The FDA kept these exemptions largely confidential and has not publicly released a comprehensive list of exempted drugs from banned factories. ProPublica has now published a list identifying over 150 exempted products, primarily from factories in India, along with their manufacturers. Some factories on the list are still banned but continue to send exempted drugs to the U.S., highlighted separately. The list was compiled using historical internet records and data from Redica Systems, a quality and regulatory intelligence company. Many companies did not respond to ProPublica's requests for comment regarding the exemptions and past issues. Some companies stated they have made improvements, while others continue to be banned but receive exemptions.