Mericon Industries Inc. – FDA Warning Letter, Aug 21, 2024

Mericon Industries, located at 8819 N Pioneer Rd, Peoria, IL, was inspected by the FDA from August 12 to 21, 2024. The inspection revealed significant violations of the Federal Food, Drug, and Cosmetic Act, including issues related to unapproved new drugs, misbranded drugs, and adulterated dietary supplements.

Key violations include:

1. **Unapproved New Drugs**: Products such as Florical 100 capsules, Florical 500 capsules, and Meribin 120 capsules were marketed with claims that classify them as drugs under the Act. These products are not FDA-approved, making their interstate commerce introduction illegal.

2. **Misbranded Drugs**: The Florical capsules lack adequate directions for use, as they are intended for conditions requiring supervision by a licensed practitioner, thus failing to meet labeling requirements.

3. **Adulterated Dietary Supplements**: The facility failed to establish necessary product specifications and quality control procedures as per CGMP regulations (21 CFR Part 111). This includes inadequate identity testing and lack of written quality control procedures, leading to potential product misidentification and quality issues.

4. **Misbranded Dietary Supplements**: The product labels do not comply with dietary supplement labeling requirements, further misbranding the products.

The FDA requires Mericon Industries to take corrective actions, including establishing proper product specifications, implementing comprehensive quality control procedures, and ensuring compliance with labeling requirements. The company must provide evidence of these corrective actions to avoid further regulatory action.