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Warning notes may precede or follow import alerts, US FDA clarifies

 
• By Anju Ghangurde

The US FDA has clarified that it does not necessarily have to stick to its generally known approach of sending warning letters to companies that have failed to meet cGMP standards, ahead of issuing a full-blown import alert.

The US FDA has clarified that it does not necessarily have to stick to its generally known approach of sending warning letters to companies that have failed to meet cGMP standards, ahead of issuing a full-blown import alert.

The FDA's office of public affairs told Scrip that the FDA takes a 'complimentary' import alert action along with the issuance of warning letters when it has 'serious concerns'...

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