FDA 483 - Southern Spectrographic Laboratory, Inc. - May 11, 2024

During inspections conducted on May 4, 8, and 11, 2024, the U.S. Food and Drug Administration (FDA) issued a Form FDA 483 to Southern Spectrographic Laboratory, Inc., a contract testing laboratory in Arlington, TX. The observations detailed significant deficiencies in the firm's laboratory control and quality systems, indicating a need for improved adherence to federal regulatory standards related to good manufacturing practices.

Key issues identified included the absence of scientifically sound and appropriate test procedures. Specifically, the firm lacked a defined procedure for preparing internal calibration standards for trace metal analysis and had no written guidelines for rounding test results. Additionally, there was no documented justification for the expiration dates assigned to standard stock solutions and calibration standards. The inspection also found that the quality control unit was not consistently fulfilling its responsibilities, as evidenced by the lack of review and approval signatures on all written procedures, despite internal protocols. A further critical observation was that all laboratory employees had not received training in current Good Manufacturing Practices (cGMP). The firm is expected to implement comprehensive corrective actions to address these observations and ensure compliance with regulatory requirements.