The FDA warning letter will then explain what corrective action measures must be taken, provide a timeline by which the company must make the changes, and describe the consequences of failing to ...

The letters, many of which were already available online, detail why the regulators initially declined to approve some drugs.

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 ...

The FDA has called a plan to publish certain complete response letters (CRLs) for medicines it has rejected after an initial ...

An announcement from Glenmark Pharmaceuticals Limited ( ($IN:GLENMARK) ) is now available. Glenmark Pharmaceuticals Limited has received a warning ...

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 Warning letters can be harbinger of formal civil and criminal investigations. If your business receives such a notice of non-compliance from the FDA, you should immediately contact an ...

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.

Elanco Animal Health (NYSE:ELAN) has received a warning letter from the FDA related to promotional materials for its canine drug Zenrelia. In the letter, the FDA said that an agency review of ...

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 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.