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Talk to a SpecialistTalk to a SpecialistKilitch Healthcare India Limited, a pharmaceutical drug manufacturer in India, was found to have significant Current Good Manufacturing Practice (CGMP) violations during an FDA inspection in October 2023. The facility operated under insanitary conditions, including visible residue near HEPA filters in sterile areas, barefoot employees without proper protective equipment in manufacturing zones, and dirty equipment used during drug production. These deficiencies rendered the company's drug products adulterated and potentially contaminated, violating federal regulations governing pharmaceutical manufacturing and product safety.