Cipla arm Medispray Goa facility classified as VAI by USFDA

Published On 2025-04-18 09:35 GMT   |   Update On 2025-04-18 09:35 GMT
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Mumbai: Cipla has announced that the United States Food and Drug Administration (USFDA) has classified the inspection at the manufacturing facility of Medispray Laboratories Private Limited, a wholly-owned subsidiary of the Company (‘Medispray’) located in Kundaim, Goa as Voluntary Action Indicated (VAI).

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

Read also: Present relevant data about dose in patient: CDSCO Panel Tells Cipla on FDC of Torsemide Plus Spironolactone 5mg/25 mg

The facility was inspected between 14th – 20th January, 2025. Following the inspection, the company had initially received one observation in Form 483,.

Read also: Cipla Goa facility gets one USFDA observation

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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