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Talk to a SpecialistTalk to a SpecialistMadhu Instruments Private Limited, a pharmaceutical manufacturer in New Delhi, India, was cited for producing sterile drugs under insanitary conditions that violated Current Good Manufacturing Practice (CGMP) requirements. FDA inspectors documented multiple facility defects including peeling paint in ISO 7 cleanrooms, blocked HEPA filters, broken tiles with residue, and improper wall patches using tape and other makeshift materials that compromised the sterile manufacturing environment. The company's response to the initial inspection findings was deemed inadequate for failing to provide sufficient detail or evidence of corrective actions necessary to achieve compliance with the Federal Food, Drug, and Cosmetic Act.