The US Food and Drug Administration (USFDA) has issued Form 483 to Lupin’s Goa plant. The Goa plant supplies drugs (oral solids and formulation) to markets in US, Europe and Japan.
The plant was inspected by the USFDA last week. During the inspection The USFDA has raised nine concerns relating to manufacturing process and quality control. The main concern for USFDA is cross contamination due to free movement from one unit to another within the plant.
Apart from this USFDA also noted unsigned test records, air handling system and stock location in the form. USFDA has given 15 days to respond to the observations before any further action is taken by the USFDA.