FDA 483 - Tom's of Maine, Inc. - May 22, 2024

Tom's of Maine, Inc., an OTC drug manufacturer in Sanford, ME, was cited for significant deficiencies during an FDA inspection. The firm failed to thoroughly investigate microbial contamination in its water system and numerous customer complaints, and lacked adequate procedures to prevent objectionable microorganisms. Additionally, the facility exhibited poor maintenance, and the quality control unit demonstrated inadequate oversight of manufacturing systems and document control.