USFDA issues one observation for Cipla Bommasandra facility

Published On 2025-05-31 06:00 GMT | Update On 2025-05-31 06:00 GMT

Mumbai: Cipla has announced that the United States Food and Drugs Administration (USFDA) has concluded the inspection with one observation at the Company’s manufacturing facility in Bommasandra, Bengaluru.

The facility was inspected from 26th to 30th May 2025.

"We hereby notify that United States Food and Drugs Administration (‘USFDA’) has conducted a current Good Manufacturing Practices (‘cGMP’) inspection at the Company’s manufacturing facility in Bommasandra, Bengaluru from 26th to 30th May 2025," Cipla informed in a BSE filing.

"On conclusion of the inspection, the Company received 1 (one) observation in Form 483. The Company will work closely with the USFDA and remains committed to address the observation comprehensively within stipulated time," it added.

An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.

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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Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

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USFDA issues one observation for Cipla Bommasandra facility

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