U.S. FDA Completes Two cGMP Inspections at Biocon Biologics' Insulins Facility in Malaysia

"The U.S. Food and Drug Administration (FDA) conducted two cGMP inspections at Biocon Sdn. Bhd's Insulins Manufacturing Facility in Malaysia, encompassing Biologics Drug Substance, Drug Product units and Quality Control laboratories, as well as the Delivery Devices unit. These inspections were conducted between July 10 and July 20, 2023.

At the conclusion of these inspections, the agency issued a Form 483 with 6 observations for Drug Substance, Drug Product units and Quality Control laboratories as well as 2 observations for the Delivery Devices unit.

These observations primarily relate to enhancing operational procedures and strengthening training programs. The inspections did not identify any data integrity breaches or systemic non-compliance.

We will submit a Corrective and Preventive Action (CAPA) plan to the U.S. FDA in a timely manner and are confident of addressing these observations expeditiously.

Biocon Biologics remains committed to global standards of Quality and Compliance."

Shares of Biocon Limited was last trading in BSE at Rs. 264.00 as compared to the previous close of Rs. 266.50. The total number of shares traded during the day was 99140 in over 2262 trades.

The stock hit an intraday high of Rs. 267.15 and intraday low of 262.80. The net turnover during the day was Rs. 26306097.00.

Source : Equity Bulls

Keywords

Biocon INE376G01013 BioconBiologics USFDA cGMPInspection InsulinFacilities Malaysia