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Talk to a SpecialistTalk to a SpecialistIndiana Chem-Port, an active pharmaceutical ingredient (API) manufacturer in India, failed to maintain equipment suitable for drug manufacturing, with FDA inspectors observing rust-like residues on product contact surfaces, deteriorated equipment held together with tape and improper fasteners, and holes in critical manufacturing components. The company lacked procedures to qualify manufacturing and quality control laboratory equipment and failed to adequately investigate the source of contamination on vessels and hoses, creating a significant risk of foreign material contaminating APIs. The facility's poor equipment maintenance and state of disrepair violated current good manufacturing practices (CGMP), rendering the manufactured drugs adulterated under the Federal Food, Drug, and Cosmetic Act.