FDA 483 - Edward Food Research & Analysis Centre Limited - July 19, 2024

Edward Food Research & Analysis Centre Limited in Kolkata, India, was cited for significant deficiencies in its control testing laboratory operations. Observations included failures to record and justify deviations from test procedures, incomplete laboratory records lacking critical data, and inadequate investigation records for unexplained discrepancies. These issues indicate a systemic lack of quality control and adherence to established procedures.