FDA 483 - AACE Pharmaceuticals, Inc. - November 22, 2024

AACE Pharmaceuticals, Inc. in Fairfield, NJ, a drug manufacturer, received a Form 483 citing significant deficiencies in its operations. The observations highlight a lack of adequate quality control unit oversight, particularly concerning contract manufacturing organizations and data integrity, alongside poor equipment and facility maintenance. Additionally, the firm failed to adhere to its own established procedures for laboratory reagent control and document management.