FDA 483 - AACE Pharmaceuticals, Inc. - August 10, 2020

An FDA inspection of AACE Pharmaceuticals, Inc. in Fairfield, NJ, revealed significant deficiencies in equipment maintenance and laboratory controls. Inspectors observed reactive equipment surfaces due to sticky tape on tablet presses, which could compromise drug product quality. Additionally, the firm failed to retain original electronic laboratory data, instead relying on cell phone photographs, and did not properly document or review "Single Injection Run" test injections.