Loading…
Grupo Quimico SRL, a contract testing laboratory in Uruguay, violated Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals, resulting in adulterated drugs. The FDA inspection from November 2023 identified critical failures including incomplete laboratory records that lacked complete test data, failure to properly review and report out-of-specification (OOS) results from high-performance liquid chromatography (HPLC) testing for multiple batches of drug products marketed in the United States, and inadequate corrective actions in the company's response. The quality unit's practice of reviewing only printed analytical results allowed unprocessed sample injections with OOS findings to go undetected and unreported until discovered by the FDA investigator.