A form 483 stating the objectionable conditions was issued to Dr. Reddy’s laboratory plant based at Hyderabad. The US FDA has audited their active pharmaceutical ingredient (API) manufacturing plant 2 at Bollaram, Hyderabad resulting into form 483 with 5 observations.
The detailed observations were not shared so far by the company officials.
Form 483 is issued to the management of firm following the inspection’s conclusion if an investigator observed any violations to the Food Drug and Cosmetic Act and related acts.
Mr Vinod Arora, Principal Advisor, IGMPI
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