Intertek USA Inc. – FDA 483, Mar 7, 2025

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.