The US FDA has issued an import alert on 20th March, on Divis Laboratories Unit II factory at Vishakapatnam, Andhra Pradesh. A few medicines have been exempted from the alert. Import alerts are typically issued when there are significant deviations from what the FDA consideres good manufacturing practices. 

The alert means that the FDA has enough evidence to allow for 'Detention Without Physical Examination' (DWPE) of these products if they reach the US, limiting them from entering the markets. Divis has not yet clarified what the potential losses from this will be, and says it is "working with third parties" to address the violations. 

Unit 2 of Divis' Vizag plant accounts for approximately 65% of total sales, and 32% of US sales. The FDA had previously issued 483 observations on the same plant after an inspection in November-December, which the company had provided replies for. Clearly the authority now feels that the issues haven't been sufficiently addressed. 

Divis' share price is sharply down today on the news, on a new 52 week low. Axis Direct analysts had issued a Hold on the stock in early February, cautioning in the report that the FDA may escalate action against the Vizag unit.