sterile manufacturing facility 2 of Agila Specialties at Bangalore.
While the company said it was "committed to work collaboratively and expeditiously with the US FDA to resolve concerns cited in the warning letter in the shortest possible time," market observers raised concerns over its impact on the sale of Agila to Mylan.
Comments from Mylan could not be obtained as an e-mailed query remained unanswered. According to Strides Arcolab, the USFDA had inspected the facility in June, resulting in the issuance of 'Form FDA 483' with observations. Strides responded by implementing corrective actions.
Meanwhile, the company said the USFDA has cleared Agila's oncology facility at Bangalore, which was inspected recently.
"This facility has cleared the inspection with "Zero 483 status," Strides said.
Earlier this month, the government approved Mylan's Rs 5,168 crore deal to fully acquire Agila Specialties from Strides. The companies had announced the deal in February.
The Bangalore-based firm has eight USFDA approved sterile manufacturing facilities. Strides Arcolab shares closed at Rs 869.10 on the BSE, down 3.45 per cent.