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

An FDA inspection of Southern Spectrographic Laboratory, Inc. in Arlington, TX, a contract testing laboratory, revealed significant deficiencies in their quality systems. Observations included inadequate laboratory controls with missing test procedures and rounding guidelines, lack of justification for expiration dates of critical standards, and a failure of the quality control unit to review and approve written procedures. Furthermore, the inspection found that all laboratory employees had not received required cGMP/cGXP training, indicating systemic issues in ensuring the quality and purity of drug products tested.