FDA 483 - Sunrider Manufacturing L P - July 03, 2019

Sunrider Manufacturing L P in Torrance, CA, an OTC drug manufacturer, received a Form 483 citing significant deficiencies during an FDA inspection from June to July 2019. The observations highlight failures in complaint handling, laboratory controls including data integrity and use of expired reagents, non-adherence to stability testing protocols, inadequate equipment cleaning documentation, and a lack of product-specific process validation. These issues collectively indicate a need for comprehensive improvements in the firm's quality management system.