Drugmakers failed to report quality issues to FDA

What they found: 49.1% of the 1,143 sites eligible to submit a FAR didn't over the four years the FDA reviewed.

• More than six in 10 were foreign plants, and the plants reviewed had a median of three new drug applications.
• 97% of sites that did submit a FAR submitted at least one follow-up report on the quality problem and corrective actions.

Go deeper: FARs have to be submitted within three days of when a manufacturer receives information that a drug or its labeling may be mistaken for another product. 

• Reporting is also required when manufacturers learn about bacterial contamination, significant chemical or physical deterioration or any failure of a batch to meet specifications laid out in a drug application, per Regulatory Focus.

Flashback: The FDA during the Trump administration imposed tougher safety and testing requirements, with a focus on raw ingredients.

• Reasons generally cited for problems range from poor quality controls to weak management oversight.