FDA 483 - Fruit Of The Earth, Inc. - February 27, 2026

An FDA inspection of Fruit Of The Earth, Inc. in Grand Prairie, TX, revealed significant deficiencies in their manufacturing operations. Observations included a failure to follow written procedures for stability chamber cleaning, resulting in unsanitary conditions, and a lack of established written test procedures for in-house raw material testing. Additionally, the firm failed to establish cleaning procedures and validations for multi-use laboratory equipment, raising concerns about cross-contamination.