Following a thorough examination, Cipla’s Medispray facility in Goa was subject to one US FDA Form 483 observation. The business is taking care of the problem by FDA deadlines. On January 20, 2025, Cipla’s share price finished at ₹1,445.90, up 0.24%.
Cipla News Today:
Pharma giant Cipla Ltd. said Monday, January 20, that Medispray Laboratories Private Ltd., its wholly-owned subsidiary in Kundaim, Goa, was inspected by the US Food and Drug Administration (FDA) from January 14–20, 2025.
According to a regulatory filing by Cipla, we hereby notify you that the United States Food and Drugs Administration (the “USFDA”) inspected the manufacturing facility of Medispray Laboratories Private Limited, a wholly owned subsidiary of the Company (the “Medispray”), located in Kundaim, Goa, from January 14–20, 2025.
One observation was made of the plant on Form 483 after the inspection. Cipla pledged to collaborate closely with the FDA to address the observation within the allotted time frame fully.
Medispray received 1 (one) observation on Form 483 at the end of the inspection. The company is dedicated to providing a thorough response to these observations within the allotted time frame, and it will collaborate closely with the USFDA,” Cipla continued.
What is Form 483?
After the inspection, the FDA inspectors issued Form 483, a record of their observations. During the closing meeting, the inspector will inform and clarify these findings to the supplier. However, the FDA’s ultimate assessment of the facility’s GMP compliance is not represented by Form 483.
Following the issuance of Form 483, the business has 15 days to respond to the FDA outlining its plans to address the US regulator’s findings.
