FDA EIR - West Agro, Inc - March 21, 2019

An FDA surveillance inspection of West Agro, Inc. dba DeLaval Manufacturing, a veterinary drug manufacturer in Des Plaines, IL, was conducted from March 18-21, 2019. This inspection, performed under Compliance Program 7371.001 for Animal Drug Manufacturing, identified significant deficiencies related to current Good Manufacturing Practice (cGMP) regulations (21 CFR Part 211), resulting in a five-point FDA 483. Key violations included repeat observations for deficient complaint investigation and handling procedures, and a lack of written justification for deviations from approved batch records. The firm also failed to thoroughly investigate out-of-specification (OOS) complaints. Furthermore, essential quality system procedures were either unwritten, not followed, or inadequate, covering corrective and preventive actions (CAPAs), return and reprocessing policies, annual product reviews (APRs), and recall protocols. A significant issue was the absence of documented training records for quality and production employees, and no written training program. Verbally discussed deficiencies included the quality unit's lack of involvement in supplier qualification, absence of internal audits, and the need for cleaning validation and established clean/dirty hold times. Overall documentation practices were also found to be deficient. The firm committed to addressing all identified issues and submitting a written response to the FDA, indicating a need for comprehensive procedural updates and improved adherence to regulatory standards.