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