Significant deviations from current GMP for manufacture of APIs at two facilities and violations of CGMP regulations for finished pharmaceuticals at another besides presence of a laboratory unknown to the regulator figure in the charges the U.S. Food and Drug Administration has made against Dr.Reddy’s Laboratories.
The details, available from a warning letter issued on November 5, shows three facilities of Dr.Reddy’s were inspected between November 2014 to March 2015. At the CTO Units VI (in Srikakulam, Andhra Pradesh) and V (Nalgonda, Telangana) facilities, “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 FDA said in its letter.
The company had acknowledged the receipt of the letter on November 6 and said it would respond with a comprehensive plan to address the observations within the stipulated time-frame of 15 days. “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,” the USFDA said in its communication.
The inspection team also “discovered” the presence of “an uncontrolled “Custom QC laboratory” at the Srikakulam facility, the existence of which was previously unknown to FDA. An official at the facility acknowledged that the laboratory was involved in CGMP analysis of APIs intended for export to the US through 2012, the regulator said. Stating that it has got nine responses from the company, between December 2014 and September 2015, the regulator said they lack sufficient corrective actions. Among the failures listed were those to maintain complete data derived from all laboratory tests, including to prevent unauthorised access or changes to data and to provide adequate controls to prevent omission of data.
