Institute of Good Manufacturing Practices India
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USFDA has made charges against DRL for significant deviations from current Good Manufacturing Practices for manufacture of APIs at two facilities and violations of CGMP regulations for finished pharmaceuticals at another facility.
The warning letter issued on November 5, shows three facilities of Dr.Reddy’s were inspected between Nov 14 to March 15. The three plants that were inspected were the Unit VI of Srikakulam Plant, Unit V at Telangana’s Miryalaguda Taluk Plant and Unit VII at the Duvvada Plant in Visakhapatnam.
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.
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. “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 US Food and Drug Administration (US FDA) has warned Dr Reddy’s Laboratories (DRL) over serious data integrity violations, placing all its new applications or supplements under a cloud. Making its letter public, US FDA has strongly worded that there are significant deviations from current good manufacturing practices (CGMP) for the manufacture of active pharmaceutical ingredients (APIs) for finished pharmaceuticals. This is likely to impact the company for new approvals by US FDA and may lead to drug import ban.