FDA EIR - West Agro, Inc. - April 03, 2019

An FDA surveillance inspection was conducted at West Agro, Inc. dba DeLaval Manufacturing in Turlock, CA, from April 2-3, 2019. The inspection focused on the company's production of non-sterile veterinary drug products, specifically teat dips used to prevent mastitis in animals. This visit was part of the eNSpect Operation ID 118947, guided by CPGM 7371.001 for Animal Drug Manufacturing Inspections, and the products are regulated under the Food, Drug, and Cosmetic Act.

While no FDA Form 483 (Inspectional Observations) was issued, the FDA investigator discussed four key areas needing improvement with the Plant Manager. These included: investigations that did not consistently confirm root causes or evaluate the impact on other batches; a lack of documented method transfer for iodine titration analysis; insufficient annual examination of reserve samples for deterioration; and annual quality reviews that did not encompass all required elements, such as trends in complaints, returns, and investigations. The company's management acknowledged these findings and indicated a commitment to inform corporate personnel and implement necessary corrections to address these discussed items.