FDA 483 - Aspire Pharmaceuticals, Inc. - July 14, 2023

Aspire Pharmaceuticals, Inc. in Somerset, NJ, an OTC drug manufacturer, received a Form 483 for significant deficiencies in laboratory controls. The inspection revealed a failure to conduct required impurity testing for numerous batches of acetaminophen-containing OTC drug products and other OTC drug products, and a lack of established impurity specifications. This is a repeat observation from a previous FDA inspection and warning letter, indicating a persistent and serious compliance issue.