483
InvaGen Pharmaceuticals, Inc.FDA 483 - InvaGen Pharmaceuticals, Inc. - February 09, 2026
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.
Record Details
Invagen Pharmaceuticals, Inc. in Hauppauge, NY, was issued a Form 483 with two observations following an FDA inspection. The firm failed to perform Performance Qualification for serialization and aggregation equipment used in drug product packaging. Additionally, the inspection found that the company did not record and review data generated from its automatic assembling packaging equipment, indicating issues with data accuracy and control.
- Office
- New York District Office
- Person
Open in Dashboard
ID · 53ec2c0f-6929-4a63-ae0b-a864da68445c