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Healwell Homeo Private Limited, a drug manufacturer in India, was cited for manufacturing homeopathic and over-the-counter drug products under insanitary conditions, including evidence of rodent and avian activity, in violation of the Federal Food, Drug, and Cosmetic Act. The facility failed to comply with Current Good Manufacturing Practice (CGMP) regulations under 21 CFR parts 210 and 211, and the company did not respond to FDA's Form FDA 483 inspectional observations despite two Agency inquiries. A shipment of drugs from the facility was detained at the border on March 19, 2025, after which the company requested a 90-day extension to address the violations.