USFDA classifies inspection at Cipla Kurkumbh facility as VAI

Mumbai: Cipla has informed in a BSE filing that the United States Food and Drug Administration (USFDA) has classified the routine current Good Manufacturing Practices (cGMP) inspection at the Company's Kurkumbh manufacturing facility as Voluntary Action Indicated (“VAI”).

VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.

Medical Dialogues team had earlier reported that the Company had received one inspectional observation in Form 483 from the USFDA at the conclusion of the inspection at the said facility.

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Established in 1935, Cipla is a global pharmaceutical company focused on agile and sustainable growth, complex generics, and deepening portfolio in its home markets of India, South Africa, North America, and key regulated and emerging markets. It has strengths in the respiratory, anti-retroviral, urology, cardiology, anti-infective, and CNS segments. It has 47 manufacturing sites around the world which produces 50+ dosage forms and 1,500+ products using cutting-edge technology platforms to cater to its 80+ markets.

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