Aurobindo Pharma said on February 29 that the United States Food and Drug Administration (US FDA) has slapped the company's injectable facility in Telangana state, with seven observations.
In an exchange filing, Aurobindo Pharma said the the US FDA inspected the injectable facility of Eugia SEZ Pvt. Ltd. from February 19-29.
Eugia is a a 100% step-down subsidiary of Aurobindo Pharma Ltd.
The company said that these observations are procedural in nature and will be responded to within the stipulated time.
The company also said that Eugia Pharma Specialities Limited has restarted production in its terminally sterilized product lines at its Unit-III, that was temporarily stopped to address some of the observations of USFDA in their
recent inspection concluded on 2nd February 2024.
The company expects to start the production in the aseptic lines of the facility in the month of March 2024. The USFDA had issued nine observations after inspecting the Eugia Unit III plant from January 22 to February 2.
The key concerns raised in the letter against Eugia Unit III included the lack of procedures to prevent microbiological contamination of drugs, incomplete lab records, and inadequate validation of aseptic processes.
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