FDA 483 - Aspire Pharmaceuticals, Inc. - February 03, 2022

Aspire Pharmaceuticals, Inc. received a Form 483 citing significant deficiencies across its manufacturing and quality control operations. Issues include inadequate laboratory controls for product specifications and impurity testing, failure to thoroughly investigate out-of-specification results and discrepancies, and poor documentation practices. The firm also lacked proper cleaning validation, test method validation, process validation, and robust quality control procedures for both drug products and dietary supplements, leading to concerns about product identity, strength, quality, and purity.