FDA 483 - Carlsbad Technology, Inc - November 05, 2021

An FDA inspection of Carlsbad Technology, Inc. in Carlsbad, CA, a manufacturer, revealed a significant deviation from written production and process control procedures. Specifically, the firm failed to follow its own procedures, resulting in the inadvertent blending of different batches of Famotidine 20 mg, yet decided to release the affected product.