(Image source from: Dr.Reddy’s Laboratories faces heavy charges against FDA})

The charges made by the U.S. Food and Drug Administration (FDA) against Dr.Reddy’s Laboratories include deviations from current GMP for manufacture of APIs at two of its facilities; violations of CGMP regulations for finished pharmaceuticals, along with presence of a laboratory not known to the regulator figure.

According to the details from a warning letter that was issued on 5 November 2015, three of the Dr.Reddy’s facilities were inspected between November 2014 to March 2015, including the CTO Units VI in Srikakulam, AP and V in Nalgonda, Telangana.

“we identified significant deviations from current GMP for the manufacture of APIs.” At Unit-VII (Visakhapatnam, AP) “we found significant violations of CGMP regulations for finished pharmaceuticals,” the letter from FDA said.

The receipt of the letter was acknowledged by the company on 6 November 2015, besides saying that it would come up with a comprehensive plan to address the observations in the given stipulated 15-days time-frame.

In its communication, the USFDA said, “These deviations and violations cause your APIs and finished drug products to be adulterated... The methods used in, or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP.”

An uncontrolled “Custom QC laboratory” at the Srikakulam facility was discovered by the inspection team, the existence of which was not known to FDA earlier.

-Sumana