Invahealth Inc.November 21, 2025

FDA 483 - Invahealth Inc. - November 21, 2025

View on Dashboard

Discuss this record with AI

ChatGPT

Claude

Perplexity

Grok

Copilot

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.

Explore Invahealth Inc.

Record Details

Invahealth Inc. in Cranbury, NJ, received a Form 483 following an FDA inspection from November 17-21, 2025. The inspection revealed two significant issues related to facility maintenance and laboratory controls for drug product manufacturing. Specifically, the firm failed to maintain a manufacturing room in good repair and did not qualify secondary reference standards used for testing and releasing OTC drug products.

Company: Invahealth Inc.
Inspection Date: November 21, 2025
Product Type: Drugs
Office: New Jersey District Office
Person: Emmanuel T. Donyina

Open in Dashboard

ID · d6d4de2e-7da3-4c3a-98b5-6f610a08a277