Noble Pharma, LLC – FDA EIR, Dec 18, 2019

An FDA Pre-Approval and cGMP surveillance inspection of Noble Pharma LLC, an animal drug manufacturer in Menomonie, WI, was conducted from December 10-18, 2019. This initial inspection, guided by compliance programs 7371.001 for Animal Drug Manufacturing and 7368.001G for Approval Evaluations of Animal Drugs under the Food, Drug, and Cosmetic Act, encompassed the firm's Quality, Facilities and Equipment, Materials, Production, Packaging and Labeling, and Laboratory Control Systems. The primary focus was on the pre-approval process for a specific animal drug product, including its manufacturing, packaging, and testing. A significant finding was the absence of any violations or deficiencies. At the inspection's conclusion, no FDA Form 483, Inspectional Observations, was issued, and no verbal items requiring corrective action were discussed with management. The report explicitly noted that no issues were identified across the reviewed systems and documents. Furthermore, no samples were collected, and no refusals were encountered during the inspection. The firm had not conducted any product recalls since commencing operations. Consequently, no specific required actions were imposed on Noble Pharma LLC, beyond the customary communication of available FDA sanctions.