FDA 483 - SUCO, Inc. - August 02, 2017

SUCO, Inc., a drug manufacturer in Silver Spring, MD, was cited for significant deficiencies in its production and process controls. The inspection revealed a lack of written procedures, inadequate batch production records, failure to determine theoretical yields, uncalibrated equipment, and insufficient identity testing for drug product components. These issues indicate a systemic failure to ensure drug product quality, strength, and purity.