FDA 483 - Symed Labs Limited (Unit I) - December 06, 2024

Symed Labs Limited (Unit I), an API manufacturer, received a Form 483 for significant deficiencies in its quality systems. The firm failed to establish adequate written procedures for production and process controls, including insufficient process validation for critical changes and lack of equipment qualification. Additionally, the inspection revealed a lack of proper written procedures for equipment cleaning and maintenance, impacting the quality assurance of drug substances.