USFDA Issues Form-483 With 11 Observations To Ipca's Manufacturing Facility In Madhya Pradesh

US FDA at the conclusion of the inspection issued form 483 with 11 observations at Ipca's manufacturing facility in Madhya Pradesh, the company announced through an exchange filing. USFDA conducted an inspection of the company's manufacturing facility in Ratlam, Madhya Pradesh from June 5 to June 13.

The company in the regulatory filing said, "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."

It further added, "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 shares

The shares of Ipca Laboratories Limited on Wednesday at 11:24 am IST were at Rs 715, down by 2.70 per cent. The shares fell close to 3 per cent on Wednesday after the company released the news.

The company had reached its 52-week low of Rs 670 on May 2023 and its 52-week high of Rs 1,033.50 on August 5, 2022.

IT search at Ipca offices in Mumbai and Sikkim

The Income Tax Department carried out survey proceedings at Ipca Laboratories offices in Mumbai and Sikkim manufacturing plants between May 30 and June 3. The company extended full cooperation and support to the officials of the Income Tax Department during survey proceedings.

Published on: Wednesday, June 14, 2023, 11:32 AM IST