Everlaan Organics, Inc. dba Maple Organics – FDA Warning Letter, Aug 19, 2025

Everlaan Organics, Inc., operating as Maple Organics, received an FDA warning letter dated August 11, 2025, following an inspection and review of records. The inspection highlighted significant violations of Current Good Manufacturing Practice (CGMP) regulations under Title 21 CFR parts 210 and 211, which resulted in the classification of their products as adulterated under section 501(a)(2)(B) of the FD&C Act.

Key violations included:

1. **Lack of Adequate Testing**: The firm failed to conduct appropriate laboratory tests to confirm the identity, strength, and purity of each batch of drug products before release, as required by 21 CFR 211.165(a).

2. **Component Testing**: The company did not verify the identity of each component used in drug products, violating 21 CFR 211.84(d)(1).

3. **Stability Testing**: The firm lacked a comprehensive stability testing program, failing to conduct long-term stability tests to ensure product quality over time, as mandated by 21 CFR 211.166(a).

4. **Documentation Deficiencies**: Incomplete batch production and control records were noted, missing critical manufacturing details, contravening 21 CFR 211.188(b).

5. **Quality Control Unit**: The company did not establish an adequate quality control unit with the necessary authority and responsibility, violating 21 CFR 211.22(a).

Additionally, several products, including "maple organics Joint Pain Relief" and "maple organics Muscle Pain Relief," were identified as unapproved new drugs and misbranded under sections 505(a) and 502 of the FD&C Act.

The FDA requires Everlaan Organics to provide corrective actions, including comprehensive testing data, revised documentation practices, and an effective quality control unit structure, to address these violations and ensure compliance with regulatory standards.