FDA EIR - NutraStar, Inc. - September 04, 2020

An FDA inspection of NutraStar, Inc., a dietary supplement contract manufacturer in Farmingdale, NJ (formerly ANS Nutrition, Inc.), was conducted from August 31 to September 4, 2020. The inspection evaluated the company's compliance with regulations for dietary supplements (21 CFR Part 111) and good manufacturing practices for human food (21 CFR Part 117, Subparts A, B, and F).

The main violation identified was the company's failure to ensure that finished dietary supplements met established product specifications for strength and composition. Specifically, for products like Men's Multi-Vitamin capsules, only two of twenty active ingredients were tested for potency and content, with the remaining components assessed via raw material testing and input calculations. This critical deficiency (cited under 21 CFR 111.73) was noted as a repeat observation from previous inspections, highlighting a persistent issue.

Following the inspection, NutraStar, Inc. received an FDA Form 483, detailing this uncorrected observation. Management was advised to provide a written response to the FDA within 15 business days, outlining planned corrective actions. The agency also communicated that further regulatory measures, including a Warning Letter, injunction, or seizure, could be pursued if the company fails to implement adequate voluntary corrections.