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Aurobindo Pharma has received 9 Form 483 observations from USFDA, for its Unit IV injectable facility.
Unit IV is situated in Pashamailaram near Hyderabad, where it manufactures sterile injectables and ophthalmics. The inspection by USFDA was conducted at this unit from February 12 to 20.
Moreover the company said to exchanges that, no observations are related to data integrity or repetitive in nature. It further added, “We are in the midst of providing a comprehensive response to the observations and would be replying to the FDA within 15 working days from the date of closure (20th February, 2018) of audit.”
