FDA 483 - Health Pharma USA LLC - December 20, 2022

An FDA inspection of Health Pharma USA LLC revealed numerous deficiencies across its manufacturing operations, indicating a systemic lack of adherence to good manufacturing practices. Key issues include inadequate laboratory controls for impurity testing, failure to follow stability testing protocols, and significant data integrity concerns with computerized systems. The firm also demonstrated poor control over equipment cleaning, environmental conditions, and batch record management, raising concerns about product quality and safety.