FDA 483 - Athea Laboratories Inc - December 20, 2023

Athea Laboratories Inc. in Milwaukee, WI, received a Form 483 with two observations related to manufacturing and quality control deficiencies. The inspection revealed issues with maintaining separate production areas due to a temporary dining area in the GMP zone and a lack of formal change control. Additionally, the firm failed to perform identity testing on incoming active pharmaceutical ingredients, relying solely on supplier Certificates of Analysis.