FDA 483 - Western Chemical Inc. - October 23, 2024

Western Chemical Inc., a manufacturer of veterinary drugs and APIs, received a Form 483 citing a significant quality control deficiency. The inspection revealed a failure to thoroughly investigate out-of-specification results for products like Syncaine and Tricaine Methanesulfonate API, including a lack of root cause analysis and assessment of impact on distributed batches. This indicates a serious lapse in their quality system for handling product deviations.