Neuland Laboratories announced that the United States Food and Drug Administration (US FDA) inspected its Unit 1 manufacturing facility at Bonthapally, Hyderabad from 17 to 21 June 2019.
The inspection has been completed with five observations given under form 483. The company has already initiated corrective and preventive actions for the observations and is confident of satisfying the FDA within the stipulated time.
This is a regular surveillance audit by USFDA, and no data integrity issues were observed during the inspection.
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