FDA 483 - Amneal Pharmaceuticals, LLC - February 10, 2022

Amneal Pharmaceuticals, LLC in Piscataway, NJ, received a Form 483 with two observations during an inspection from January 24 to February 10, 2022. The inspection revealed failures in following procedures to prevent microbiological contamination in drug products and a lack of qualification for equipment used in manufacturing commercial and ANDA stability batches. These issues indicate significant deficiencies in the firm's quality control and manufacturing processes.