In the new warning letter sent to Perrigo, the FDA details that Cronobacter had been identified in finished formula products on multiple occasions by the company: in two products "during a ...

FDA action aligns with a growing chorus of scientists, public health experts, and advocates warning against the public health ...

A young Pittsburgh-area police officer died by suicide and pointed to Lasik eye surgery complications as the reason.

The U.S. Food and Drug Administration issued letters to several companies -- including major pharmacy chains -- this week, warning them against manufacturing or selling unapproved eye products.

The Instagram post was not submitted to the FDA for review, which is required for any drug labeling or promotional advertising. According to the warning letter, dated May 29, Sprout has 15 ...

Then if you do happen to get an FDA warning letter, you absolutely MUST respond and correct the issues. Otherwise, expect increased escalation from the agency. You could end up flushing $400,000 ...

“FDA has been fully committed to actively implementing this critical new law regulating non-tobacco nicotine products since its passage, and the warning letters announced today are just the ...

The Food and Drug Administration laid out these inspection findings in warning letters, accusing the companies of committing “significant violations” of federal laws, according to an FDA staff ...

The warning letter follows inspections by the FDA at Dexcom’s manufacturing facilities in San Diego and Mesa, Ariz., and identified concerns in manufacturing processes and quality management.

The FDA said Tuesday that it has issued a warning letter to the Evansville, Indiana, family-owned company because inspections of manufacturing plants revealed evidence of violations.