Tyler Patchen 
News Reporter

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.

Inspectors found that Ipca did not conduct the correct contamination testing of a drug substance that was redacted from the report and therefore was not aware of potential hazards. Laboratory tests on manufactured APIs were found to be deficient by inspectors, as were the cleaning records and calibration for lab equipment.

Endpoints News reached out to Ipca for more information but did not get a response by press time.

Ipca Laboratories cited for quality issues at India facility that produces API
The FDA in April identified several quality issues at Ipca’s manufacturing site in Piparia, India. At that time, the regulator said the site had not properly investigated several batches of products, had shared results without getting to the root of issues in some cases, and had not properly been followed.

https://endpts.com/