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Talk to a SpecialistTalk to a SpecialistKenil Healthcare Private Limited, a drug manufacturer in Gujarat, India, was cited for significant Current Good Manufacturing Practice (CGMP) violations in the production of over-the-counter pharmaceutical products following an FDA inspection in December 2024. The company failed to adequately clean and maintain manufacturing equipment and filling rooms, with inspectors observing mold and dirt on walls, soiled air handling units, unidentified product buildup in manufacturing vessels, and cross-contamination issues between different drug products. These deficiencies rendered the firm's drug products adulterated under the Federal Food, Drug, and Cosmetic Act due to inadequate controls that could compromise product safety, identity, strength, quality, and purity.