Cipla Goa facility gets one USFDA observation
Mumbai: Cipla has announced that the United States Food and Drugs Administration (USFDA) has concluded an inspection at the manufacturing facility of Medispray Laboratories Private Limited, a wholly owned subsidiary of the Company located in Kundaim, Goa with one observation.
The facility was inspected from 14th – 20th January, 2025.
"The Company will work closely with the USFDA and remains committed to address these observations comprehensively within stipulated time," Cipla said in a BSE filing.
"On conclusion of the inspection, Medispray received 1 (one) observation in Form 483," 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.
