Institute of Good Manufacturing Practices India®

Form 483 to Biocon's API facility: USFDA


A pre-approval inspection and good manufacturing practice examination was conducted by the US health regulator at the API manufacturing facility of Biocon. The company has received a Form 483 with five observations.

Form 483 is issued to the company after the USFDA inspectors found the violations of the Food Drug and Cosmetics Act and related Acts.

The inspection was conducted between 20-24 January 2020 resulting is the issuance of Form 483.

The company officials will prepare a Corrective and Preventive Action Plan and respond to the FDA within the stipulated timeline.