Sun says US FDA has issued an EIR for Dadra API plant
The Indian drug firm announced the EIR in a Bombay Stock Exchange filing, explaining the US agency had closed its investigation of operations at the facility.
The US Food and Drug Administration (FDA) raised concerns about the Dadra facility in April.
Inspectors who visited the active pharmaceutical ingredient (API) and oral solid dosage form facility on April 13 issued a Form 483 that included 11 observations, some of which were critical.
Sun, which has never provided details of the Form 483, referenced the April inspection in the latest filing.
"This is with reference to our letters dated April 21, 2017 to the stock exchanges providing our clarification on the US FDA inspection at the Company's Dadra facility wherein interalia we had indicated that we were then in the process of responding to the Form-483 observation letter issued by the US FDA post the inspection completed on April 13, 2017. We had further stated that if there are any material developments related to this inspection, we will promptly inform the stock exchanges."
Sun went on to say: “We are now pleased to inform you that the above referred inspection is closed.
“In this respect, we have received a communication from the US FDA releasing a copy of the Establishment Inspection Report (EIR) in respect of the above inspection based upon our responses to the said observation letter.”
