Biocon tanks on Form 483
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Biocon fell as much as 9% today to Rs.341 levels; it has recovered from there but remains amongst the top losers on the BSE since the opening bell.
The stock has tanked after the US FDA issued 10 observations pointing at aseptic practices after an inspection at the drugmaker's plant in Bengaluru.
The company has not issued this development but a visit to the FDAs website shows the 10 observations issued to the company under Form 483.
The FDA inspection took place on May 25th, June 1st and June 3rd.
For a complete report on this Form 483, follow this link: https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/cderfoiaelectronicreadingroom/ucm569851.pdf
Right from discrepancies in the procedures to employees lacking training, the 10 observations are very pertinent.