FDA says Ipca Labs failed to address quality issues with bad API batches
Ipca Laboratories, an India-based maker of active pharmaceutical ingredients, was cited for several quality and testing issues during a recent FDA inspection.
The FDA inspected an Ipca manufacturing facility in Ratlam, India, between June 5 and June 13, and investigators made a total of 11 observations.
The FDA said the company failed to properly investigate root causes for deficient API batches. In April, Ipca had received a complaint saying there were “metal-like particles and magnet particles” in some products. The regulator also said the facility’s quality unit did not issue a recall of an unnamed product that did not meet specific impurity standards.
Unlock this article instantly by becoming a free subscriber.
You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.
