FDA EIR - Hetero Labs Limited (Unit V) - December 16, 2016

The U.S. Food and Drug Administration (FDA) conducted a comprehensive Good Manufacturing Practice (GMP) inspection of Hetero Labs Limited Unit V in Jadcherla Mandal, India, from December 7 to December 16, 2016. This pre-announced inspection, guided by drug manufacturing inspection policies, focused on the facility's quality, facilities and equipment, laboratory, and production systems for finished drug products intended for the U.S. market, operating under the regulatory framework of the FD&C Act and 21 CFR Part 211. Eight significant observations were documented on an FDA Form 483. Major findings included the quality control unit not fully adhering to its procedures, evidenced by the documented destruction and alteration of commercial batch manufacturing records immediately prior to the inspection, and controlled documents found discarded in scrap and trash areas. Other critical issues involved incomplete batch production and control records, inadequate investigation and record-keeping for drug complaints, and poorly cleaned and maintained equipment and utensils displaying residues and damage on product contact surfaces. Furthermore, the company failed to document deviations from production time limits, lacked established and documented accuracy for test methods, and showed insufficient controls over computer systems, including numerous unexplained user aborts in the QC laboratory. Hetero Labs management acknowledged the inspectional concerns and committed to submitting a comprehensive written response to the FDA within fifteen business days to address the identified deficiencies.