Regulatory woes continue for Biocon, as United States Foods and Drug Administration (USFDA) has reportedly issued a form 483 with 10 observations to its Bangalore plant. The US drug regulator found lapses of current good manufacturing practices (cGMP) at the company’s small molecule injectable plant in Bengaluru.
The USFDA issued a Form 483 - a form listing violations - after an inspection between May 25 and June 3. The FDA issues a Form 483 if its investigators spot any conditions that in their judgement may constitute violations of the US Food Drug and Cosmetic (FD&C) Act and related laws.
Biocon is India’s largest and Asia’s leading Biotechnology Company with a strategic focus on biopharmaceuticals and research services. It is a fully integrated, innovation-driven biopharma enterprise offering affordable solutions for chronic diseases to patient's worldwide.