USFDA completes Waluj facility inspection: Wockhardt

Drug firm Wockhardt, which has been under the USFDA's scanner, today said that the American health regulator has completed the inspection of its Waluj facility in Maharashtra.
"Inspection of our manufacturing unit at H14/2 Waluj, Aurangabad, Maharashtra by United States Food and Drug Administration (USFDA) has since been completed," Wockhardt said in a filing to the BSE.
In April this year, Wockhardt had recalled 13 drugs in the US, manufactured at its two units at Chikalthana and Waluj in Maharashtra, which were under import restrictions from the USFDA.
The company had then said that during an inspection of its facilities at L1-Chikalthana and Waluj in Aurangabad, the USFDA had made some observations pertaining to batches of some products manufactured prior to the import alerts.

"As a measure of preparedness and as an abundant precaution, the company has now decided to recall, as a part of remedial measure, all the remaining batches (of drugs) in the US market that were manufactured prior to the USFDA import alerts even though there is no evidence of risk to patient safety from the products currently available in the US market," Wockhardt had added.
The company's Waluj facility, which makes injectables and solid dosages, was put under import restrictions by the USFDA in 2013.
Wockhardt shares today closed 10.67 per cent up at Rs 1,575.05 apiece on the BSE.