FDA EIR - Joint Stock Company Grindeks - August 24, 2018

An FDA inspection of Joint Stock Company Grindeks, an Active Pharmaceutical Ingredient (API) manufacturer in Riga, Latvia, was conducted from August 20-24, 2018. This routine assessment focused on compliance with current Good Manufacturing Practices (CGMP) for APIs, consistent with regulatory frameworks including ICH Q7A. The inspection identified eight significant deficiencies. These included a repeat observation concerning inadequate controls over electronic laboratory data and a failure to regularly review audit trails on analytical instruments. A critical issue of data integrity emerged with the manipulation and backdating of laboratory test records. Other violations involved a deficient raw material sampling plan that did not ensure representative samples, and incomplete analysis of APIs according to their quality specifications. Furthermore, inadequate maintenance was noted for production equipment, alongside a lack of cleaning between batches during campaign manufacturing. The firm also failed to verify calibration standards used for equipment, and its investigations into out-of-specification results and deviations were insufficient in identifying root causes. Joint Stock Company Grindeks acknowledged the eight inspectional observations (FDA-483) and committed to providing a written response to the FDA within fifteen working days. The company also agreed to implement necessary corrective actions, such as initiating comprehensive audit trail reviews, enhancing data integrity training for personnel, and improving raw material sampling procedures and tools.