FDA 483 - Acharya Chemicals - March 15, 2024

During an inspection conducted from March 11-15, 2024, the U.S. Food and Drug Administration (FDA) issued a Form 483 to Acharya Chemicals, a manufacturer located in Thane, Maharashtra, India. The primary observation cited was a "Failure to adequately investigate out-of-specification results and implement appropriate corrective actions." The inspection revealed that Acharya Chemicals failed to conduct thorough investigations into out-of-specification (OOS) results, lacked sound scientific rationale for omitting Phase II investigations, and implemented inadequate corrective and preventive actions (CAPA). Specific examples included an OOS for impurity testing where the firm identified an inconsistent mobile phase but did not re-qualify the supplier. Another OOS for impurity testing involved an analyst's use of sonication; while the standard operating procedure (SOP) was updated, no method validation CAPA was performed. Furthermore, a raw material OOS resulted in material rejection without a Phase II investigation or supplier re-qualification. These observations indicate a need for Acharya Chemicals to enhance its quality system, particularly in the areas of OOS investigations and CAPA effectiveness, to ensure compliance with good manufacturing practices and prevent recurrence of quality failures. The firm is expected to address these deficiencies to the FDA.