FDA 483 - West Pharmaceutical Services AZ, Inc - December 13, 2022

An FDA inspection of West Pharmaceutical Services AZ, Inc. in Tempe, AZ, from December 12-13, 2022, identified significant deficiencies in the maintenance of a warehouse used for storing drug product components. The facility's Building (b)(4) Warehouse was found to have water leaks, pooling water, damaged equipment, and insect infestation. These conditions indicate a lack of adequate control over the environment for holding drug product materials.