483
Health Pharma USA LLCHealth Pharma USA LLC – FDA 483, Sep 22, 2021
Record Details
An FDA inspection of Health Pharma USA LLC in Rahway, NJ, revealed significant deficiencies in laboratory controls, quality systems, production, and packaging. The firm failed to qualify working standards, maintain proper computer system controls, calibrate equipment, and adequately document laboratory and batch records. These issues indicate a lack of adherence to good manufacturing practices for drug products.
View Company Profile
ID · ab32da9f-e10a-4cef-bbb3-dbfad08ebda2
Other documents for Health Pharma USA LLC
- 483 - 2025-11-18
- 483 - 2024-07-03
- 483 - 2022-12-20
- WARNING_LETTER - 2019-06-03
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.