FDA 483 - Health Pharma USA LLC - December 20, 2022
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
ID · 782420cb-4cd0-4ad6-9fef-afa29634fb72