FDA WARNING_LETTER - global vitality, inc. - April 24, 2019

On April 16, 2020, the FDA issued an amended Warning Letter to Enzyme Process, Inc. following an inspection from April 15-24, 2019, at their Chandler, Arizona facility. The letter identified serious violations of the Federal Food, Drug, and Cosmetic Act.

Several products, including Liverchol, Celery Seed, and Zymepro, were deemed unapproved new drugs and misbranded. Claims on the company's website, such as "intended for use in the cure, mitigation, treatment, or prevention of disease," established their drug classification. These products are not generally recognized as safe and effective, making them "new drugs" requiring FDA approval. Additionally, they are misbranded for lacking adequate directions for layperson use, particularly for conditions requiring professional supervision.

The company also violated dietary supplement Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 111). Key deficiencies included: 1. **Quality Control Failure:** Releasing products (Advance CardioZyme Capsules Lot #5237, Pro-T-Complex Capsules Lot #4897) with components not meeting identity specifications. 2. **Invalid Test Methods:** Using scientifically invalid methods (e.g., (b)(4) for Thyroid HP) to verify ingredient identity. 3. **Inadequate Laboratory Controls:** Failing to establish and follow approved laboratory control processes for selecting standard reference materials (e.g