# FDA 483 - Vantage Specialty Ingredients - May 02, 2022

Source: https://www.globalkeysolutions.net/records/483/vantage-specialty-ingredients/90bf18b2-54b5-4f54-8015-4b3e7c057b8b

> FDA 483 for Vantage Specialty Ingredients on May 02, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Vantage Specialty Ingredients
- Inspection Date: 2022-05-02
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: Vantage Specialty Ingredients, Inc. in Linden, NJ, was inspected from April 26 to May 2, 2022, and cited for a significant issue regarding computer system validation. The firm failed to validate its Enterprise Resource Planning (ERP) and Laboratory Information Management System (LIMS) software, leading to unchecked accuracy of data for incoming and outgoing Active Pharmaceutical Ingredients and excipients. This indicates a lack of control over critical data management systems.

## Related Documents

- [EIR - 2016-02-08](https://www.globalkeysolutions.net/records/eir/vantage-specialty-ingredients/d38fc29f-8a57-4938-a22e-e0ae6ee49196)

## Related Officers

- [Adetutu M. Gidado](https://www.globalkeysolutions.net/people/adetutu-m-gidado/6c4e8cf3-0eea-4903-9ca5-e8e2d683621d)
- [Ankur C. Patel](https://www.globalkeysolutions.net/people/ankur-c-patel/602c7d14-2c48-4929-a07b-6e4c235d7f13)

Company: https://www.globalkeysolutions.net/companies/vantage-specialty-ingredients/61ceb95e-844d-4b4b-a2e9-cf927d214d27

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