USFDA issues 11 observations to Ipca Labs Ratlam facility

Written by Ruchika Sharma Published On 2023-06-14T13:30:50+05:30 | Updated On 14 Jun 2023 1:31 PM IST

USFDA issues 11 observations to Ipca Labs Ratlam facility

Ratlam: Ipca Laboratories Limited has announced that the Company has received eleven observations from the United States Food and Drug Administration (USFDA) after an inspection at the Company’s APIs manufacturing facility situated at Ratlam, Madhya Pradesh.

The inspection was held from 5th June, 2023 to 13th June, 2023.

"At the conclusion of the inspection, the US FDA issued a Form 483 with 11 (eleven) observations," the Company stated in a BSE filing.

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.

"The Company will submit its comprehensive response on these observations to the US FDA within the stipulated time and shall work closely with the agency to resolve these issues at the earliest. The Company takes the quality and compliance issues with utmost importance and remains committed to maintain the highest standards of quality and compliance across all its manufacturing facilities," Ipca further stated.

Read also: Ipca Labs gets 3 USFDA observations for Piparia facility

Ipca Laboratories Limited is an Indian multinational pharmaceutical company headquartered in Mumbai. The Company was founded by group of businessmen and medical professionals in 1949. It produces theobromine, acetyl thiophene, and p-bromotoluene as active pharmaceutical ingredients (APIs). Ipca sells these APIs and their intermediates globally. Ipca is a fully-integrated pharmaceutical company that manufactures over 350 formulations and 80 APIs for various therapeutic segments.

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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