# FDA 483 - Invahealth Inc. - November 21, 2025

Source: https://www.keypedia.com/records/483/invahealth-inc/d6d4de2e-7da3-4c3a-98b5-6f610a08a277

> FDA 483 for Invahealth Inc. on November 21, 2025. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Invahealth Inc.
- Inspection Date: 2025-11-21
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: 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.

## Related Documents

- [483 - 2021-12-15](https://www.keypedia.com/records/483/invahealth-inc/24d98ed0-2799-45fb-bc3d-157b431fa299)

## Related Officers

- [Emmanuel T. Donyina](https://www.keypedia.com/people/emmanuel-t-donyina/a8f23469-487e-490d-bf02-41b2a60bb396)

Company: https://www.keypedia.com/companies/invahealth-inc/53c7914b-bc86-448a-b2de-5b49cc55848d

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248