# FDA 483 - Vantage Specialty Ingredients, Inc. - January 23, 2026

Source: https://www.keypedia.com/records/483/vantage-specialty-ingredients-inc/64ab3a25-21d0-4a4e-9357-3e1d9095a585

> FDA 483 for Vantage Specialty Ingredients, Inc. on January 23, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Vantage Specialty Ingredients, Inc.
- Inspection Date: 2026-01-23
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: Vantage Specialty Ingredients, Inc. in Fairfield, NJ, a repacker/relabeler, was cited for significant deficiencies in its quality unit, laboratory controls, and data integrity during an FDA inspection. Observations included failures in annual product reviews, change control, sample examination, vendor qualification, computerized system controls, analytical method validation, equipment qualification, stability testing, employee training, and customer complaint investigations. These issues indicate a broad lack of adherence to current good manufacturing practices for Bulk Active Pharmaceutical Ingredients.

## Related Officers

- [Tanya R. Syffrard](https://www.keypedia.com/people/tanya-r-syffrard/a78a42b3-6cef-46d9-9698-ec6082956477)
- [investigator](https://www.keypedia.com/people/ifechimere-i-okafor/c48399bf-47d9-4562-9130-1e6731eca07d)

Company: https://www.keypedia.com/companies/vantage-specialty-ingredients-inc/773b25e2-afb1-49f5-89f0-3adc15355805

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