FDA 483 - Fruit of the Earth Inc. - March 21, 2025

Fruit of the Earth Inc., an OTC drug manufacturer in Fort Worth, TX, received an FDA Form 483 citing two significant observations. The inspection revealed deficiencies in the firm's control systems for preventing contamination and mix-ups, including inadequate segregation of materials and undefined areas for equipment. Additionally, the company failed to establish and follow proper written procedures for equipment cleaning and maintenance, specifically regarding cleaning validation and equipment status identification.