FDA Warns India-Based Ipca Laboratories of Data Integrity Violations at Three Plants

Source: www.raps.org

Feb 16, 2016

The U.S. Food and Drug Administration (FDA) this month released a warning letter that was sent to India-based Ipca Laboratories after inspections at three of its manufacturing facilities revealed data integrity violations, reports Zachary Brennan of the Regulatory Affairs Professionals Society (RAPS).

All three of the plants are already banned from sending products to the U.S.

The warning letter reveals that inspectors found “systemic data manipulation” at Ipca’s Ratlam facility in Madhya Pradesh, “including actions taken by multiple analysts, on multiple pieces of testing equipment, and for multiple drugs."

According to the RAPS report, at the company’s Pithampur site, the FDA said the firm has “no way to ensure that the tests you use to evaluate the quality of incoming raw materials are accurate or reliable.”

And at the Piparia Silvassa manufacturing facility, the FDA said Ipca lacks an evaluation of the acceptability of its media supplier, the adequacy of laboratory controls and a determination of whether laboratory personnel (including supervisors) are appropriately qualified to detect and correct these deviations.

Click here to read the full report from RAPS, warning letter from the FDA and learn what the regulator is requesting of Ipca.