# FDA 483 - Intertek USA Inc. - March 07, 2025

Source: https://www.keypedia.com/records/483/intertek-usa-inc/f6d61ea3-e37e-4c8f-baf6-9fa58b8576f8

> FDA 483 for Intertek USA Inc. on March 07, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Intertek USA Inc.
- Inspection Date: 2025-03-07
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: Intertek USA Inc. in Whitehouse, NJ, a control laboratory, was issued a Form 483 with two observations following an FDA inspection. The firm demonstrated deficiencies in its electronic record-keeping and audit trail practices, failing to ensure data trustworthiness and reliability. Additionally, the quality control unit did not fully adhere to its established procedures, leading to issues with analytical result investigations, expired laboratory solutions, and balance calibration records.

## Related Officers

- [investigator](https://www.keypedia.com/people/christian-d-lynch/3b2748d3-3800-4538-939d-71a33dca0b2d)
- [FDA_PERSONNEL](https://www.keypedia.com/people/lizaida-perez/686fbdca-bfd7-4a73-990a-d8a97e6b88b7)

Company: https://www.keypedia.com/companies/intertek-usa-inc/2c61102d-28cb-4e8b-b5c0-01d3148f07d0

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