The facility in Alathur was visited by the US regulator last August according to Orchid, which announced it received an FDA Establishment Inspection Report (EIR) in a filing on the Bombay Stock Exchange (BSE) today.
Orchid makes antibiotic active pharmaceutical ingredients (APIs) – primarily cephalosporin - at the site.
Operations at the facility were suspending in December as a result of flooding, which had a negative impact on the firm according to managing director K Raghavendra Rao.
“Despite the business interruption sustained on account of unprecedented torrential rains in December 2015, the company is confident of regaining the traction on account of growth measures being initiated including launch of new products and long term financial arrangements.”