VitalHealth Tech Inc. – FDA Warning Letter, Jun 18, 2014

On May 29 - June 18, 2014, an FDA inspection of VitalHealth Tech, Inc. revealed serious violations of Current Good Manufacturing Practice (CGMP) regulations for dietary supplements (21 CFR Part 111), rendering products like "Kids Mighty Vites," "Omni Jr." wafers, and "Weight Loss 4" adulterated.

Key deficiencies include: 1. **Failure to establish component specifications (21 CFR 111.70(b)(2)):** The firm lacked specifications for dietary ingredient components, such as those in "Kids Mighty Vites" and "Weight Loss 4." Their response was inadequate, providing only one approved specification and lacking supporting documentation for others. 2. **Failure to verify finished product specifications (21 CFR 111.75(c)):** The firm's method for verifying strength and composition of ingredients like soy lecithin and hesperidin in "Kids Mighty Vites" and "Omni Jr. Wafers" was inadequate, relying on "Based on Input" or "Ensured by documented control" rather than testing. 3. **Improper component storage conditions (21 CFR 111.455(a)):** Raw materials like Dry Vitamin A Acetate 500 and Lactobacillus Acidophilus were not stored under appropriate temperature/humidity conditions, with no monitoring in warehouse/pharmacy areas.