Cipla gets 6 USFDA observations for Maha facility

Written By :  Ruchika Sharma
Medically Reviewed By :  Dr. Kamal Kant Kohli
Published On 2024-04-05 06:21 GMT   |   Update On 2024-04-05 06:21 GMT
Advertisement

Mumbai: Cipla has received six inspectional observations in Form 483 from the United States Food and Drug Administration (USFDA) at the conclusion of a routine current Good Manufacturing Practices (cGMP) inspection at the manufacturing facility of the Company located in Patalganga, Maharashtra, India.

The inspection was held from 28th March 2024 to 4th April 2024.

"The Company will work closely with the USFDA and is committed to address these comprehensively within the stipulated time," Cipla stated.

Advertisement

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. 

Read also: Cipla Gets CDSCO Panel Nod To import, market Human Insulin inhalation powder with inhaler

Cipla Limited is an Indian multinational pharmaceutical and biotechnology company headquartered in Mumbai, India. Khwaja Abdul Hamied founded the Company in 1935 in Mumbai. Cipla has extended its presence to 80+ countries providing over 1,500 products across various therapeutic categories in 50+ dosage forms. The Company is also deepening its presence in the key markets of India, South Africa, and the U.S. among other economies of the emerging world.

Read also: Cipla Gets CDSCO Panel Nod To import, market Human Insulin inhalation powder with inhaler

Tags:    

Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.

NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.

Our comments section is governed by our Comments Policy . By posting comments at Medical Dialogues you automatically agree with our Comments Policy , Terms And Conditions and Privacy Policy .

Similar News