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MMC Healthcare Ltd., a drug manufacturer in India, was cited for significant Current Good Manufacturing Practice (CGMP) violations in finished pharmaceuticals. FDA inspectors found that the company failed to establish an adequate quality control unit and discovered that process validation reports for tablets and capsules contained backdated signatures, added data, and replaced pages, with multiple managers admitting to participating in these practices. The violations rendered the company's drug products adulterated under federal law, as their manufacturing methods, facilities, and controls did not conform to required standards.