# FDA 483 - SENSONICS, INTERNATIONAL - February 10, 2025

Source: https://www.keypedia.com/records/483/sensonics-international/46beb762-1e95-42b7-adb1-98da91eea0f0

> FDA 483 for SENSONICS, INTERNATIONAL on February 10, 2025. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SENSONICS, INTERNATIONAL
- Inspection Date: 2025-02-10
- Product Type: other
- Office Name: New Jersey District Office
- Summary: SENSONICS, INTERNATIONAL, a manufacturer in Haddon Heights, NJ, was cited for significant deficiencies in its quality system during an FDA inspection. Observations included inadequate procedures for internal quality audits, a failure to conduct proper supplier evaluations, and a lack of clear instructions for supplier scoring. Additionally, the firm lacked process validation for a Flexographic Press used in product labeling.

## Related Officers

- [Shirley S. Wen](https://www.keypedia.com/people/shirley-s-wen/eafbc8e5-a0ac-443a-adaf-ced505f77842)

Company: https://www.keypedia.com/companies/sensonics-international/e9903dd5-0757-4d05-8a22-b7fd2f80a7bc

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