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Shilpa Medicare’s bulk drugs units in Raichur, Karnataka, violated the same manufacturing norm of the US Food and Drug Administration for the second inspection in a row, a Cogencis report said. The US drug regulator called out the company’s unit-I and unit-II for not maintaining cleanliness of equipment and utensils, following inspection of the facility from January 16-19. The observation is a repeat offence from the drug regulator’s previous inspection of the same facilities in December 2016, after which it had issued a Form 483. USFDA Inspector June Page cited instances of equipment being classed as ‘cleaned’ despite instances of residual dust, corrosion and discolouration, the report added. Reacting to the news, shares of the company plunged to a low of ₹538 on the NSE, but recovered to close at ₹582.20, against the previous day’s close of ₹580.75.
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