USFDA rescinds letter to Aurobindo Pharma unit

Aurobindo Pharma on Friday said the US Food and Drug Administration (USFDA) inspection of its Unit IV, a general injectable formulation manufacturing facility here, is “still open and under review.”

This follows the regulator rescinding a 90-day VAl (Voluntary Action Initiated) letter it had issued to the company on February 18. In a regulatory filing, the Hyderabad-headquartered drug-maker said it has received a communication from USFDA that the inspection at the facility, conducted from November 4-13, is “still open and under review, by way of rescindment of 90-day VAl letter that was issued by them on Feb. 18.” On Feb. 19, following Aurobindo Pharma intimating the exchange about receipt of the Establishment Inspection Report (EIR) with VAl status from the USFDA, the company shares gained ₹102.05 apiece or over 20% to close at ₹602.25. On Thursday, the shares closed lower at ₹599.55 each. The USFDA had in November, after inspection, said it had been issued a Form 483 with 14 observations. The company also said that “we believe none of these observations are related to data integrity issues.”