FDA 483 - Western Chemical Inc. - April 14, 2022

Syndel USA, a veterinary drug manufacturer in Ferndale, WA, was cited for significant deficiencies across four observations. The inspection revealed inadequate investigations into product stability failures, incomplete batch production records lacking critical raw material identification and investigation documentation, and failures in maintaining sanitary conditions and proper material handling in the warehouse. Additionally, the firm did not perform complete elemental impurity testing for its drug products.