Curexa - East, LLC dba Curexa – FDA Warning Letter, Sep 9, 2022

On September 13, 2023, the FDA issued a Warning Letter to Curexa – East, LLC dba Curexa, following an inspection from August 29 to September 9, 2022. The inspection revealed serious deficiencies in drug product production, leading to the issuance of a Form FDA 483. The FDA determined that Curexa produced adulterated drug products under Section 501(a)(2)(A) of the FDCA because products were prepared, packed, or held under insanitary conditions, risking contamination.

Specific violations included non-microbial contamination in the production area and inadequate cleaning of utensils, components, or containers when producing hazardous drugs, potentially causing cross-contamination. The FDA cited sections 301(a) and 301(k) of the FDCA, prohibiting the introduction of adulterated drugs into interstate commerce and any act that results in adulteration while a drug is held for sale after interstate shipment.

Curexa's October 7, 2022, response to the FDA 483 was deemed insufficient. Corrective actions for insanitary conditions lacked adequate supporting documentation, such as photos of remediated hoods and purchase orders/timetables for HEPA filter replacement. Proposed remediations were also found deficient; for example, blue residue remained in an air conditioning unit, and the V-blender cleaning procedure was inadequate. Additionally, the firm'