Discover industry-tested approaches to strengthen quality systems and navigate regulatory scrutiny in this comprehensive ...

The FDA often issues warning letters after initially flagging its concerns to a company and determining the company’s ...

The Agency is requesting additional confirmatory clinical evidence before a decision can be made. The Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to Telix ...

A seafood company failed to follow federal safety rules to prevent potential botulism contamination. A business was hawking dietary supplements with the misleading claim that they’d cure, treat ...

The FDA has not published more than a dozen letters that flagged hazards at food companies, including potential contamination, two sources said. NBC Universal, Inc. A seafood company failed to ...