FDA 483 - Transom Symphony OPCO LLC - September 27, 2022

Transom Symphony OPCO LLC, a contract manufacturer in Rantoul, IL, received an FDA Form 483 citing significant deficiencies. The inspection revealed a lack of appropriate controls over computer systems, leading to potential data integrity issues. Additionally, the firm's quality control unit failed to adequately follow procedures for environmental monitoring, equipment calibration, and preventive maintenance of manufacturing lines.