FDA 483 - CELESTE INDUSTRIES CORPORATION - February 28, 2025

CELESTE INDUSTRIES CORPORATION, a manufacturer in Easton, MD, was inspected and cited for significant deficiencies in its quality control and manufacturing processes for hand sanitizer products. Key issues include inadequate microbial testing methods, insufficient personnel training, poor laboratory controls, lack of computer system security, and failure to perform component identification and annual product reviews. These observations indicate a systemic lack of adherence to Good Manufacturing Practices.