Biocon tumbles 9% as USFDA issues 10 observations

NEW DELHI: Shares of Biocon tumbled over 9 per cent on Friday after the US drug regulator USFDA issued 10 observations on the drugmaker’s Bangalore plant.

Following the development, Biocon dropped 9.13 per cent to hit a low of Rs 341 on BSE. It however ended the day at Rs 357.35, down 4.78 per cent.

The FDA inspection took place on May 25, June 1 and June 3.

“They are inspectional observations and do not represent a final agency determination regarding your compliance,” USFDA said in a note.

USFDA observed inadequate procedures by the company to prevent microbiological containment of drug products, unexplained discrepancy in batches of the same product, no complete records of data derived from all tests to assure compliance with standards, lack of authority and responsibility of the quality control unit to accept or recent drug, among others.

USFDA said that the employees engaged in the manufacture and processing of a drug product lack the training and experience required to perform their assigned functions.

Besides, the lab controls do not include the establishment of scientifically sound and appropriate specifications and test procedures, USFDA said.