Biocon receives Form 483 containing 8 observations

Biocon, India’s largest biopharmaceutical company, informed the exchanges on Saturday that the company has received a Form 483 with eight observations for two of its new facilities in Bengaluru.

In the statement, the company stated that the U.S. FDA conducted a Pre-Approval Inspection (PAI) at two of our new Biologics Manufacturing facilities in Bengaluru from Sep 10 to Sep 19, 2019. The inspection included a new Drug Substance (DS) and a Drug Product (DP) unit.

At the conclusion of the inspection, the company received a Form 483 with four observations for the new DS facility, three observations for the new DP facility and one general observation. However, the company is confident of addressing these observations effectively through a Corrective and Preventive Action (CAPA) plan, expeditiously.

The FDA Form 483 warns the company’s management of objectionable conditions. Observations are made when in the investigator’s judgment, conditions or practices observed would indicate that any food, drug, device or cosmetic has been adulterated or is being prepared, packed, or held under conditions whereby it may become adulterated or rendered injurious to health.

Biocon has not updated on the details of the observations issued by the FDA. But the company spokesman has said – “The Pre-Approval Inspection of our new facilities does not have any impact on our current commercialization plans from our existing facilities."

On Monday, shares of Biocon Ltd. have opened in BSE at Rs.229.00 on Friday as compared to the previous close of Rs. 228.00. The stock hit an intraday high of Rs. 229.90 and intraday low of 225.60. At 09:30AM, the stock was trading at Rs. 226.05, down by 0.86 points.