nutritional laboratories international, inc. – FDA Warning Letter, Sep 28, 2021

The FDA inspected the facility at 1001 S. 3rd Street West, Missoula, Montana, on September 14-17 and 28, 2021, and collected product labels. The inspection revealed serious violations of Current Good Manufacturing Practice (CGMP) for dietary supplements (21 CFR Part 111), rendering products adulterated under section 402(g)(1) of the Act.

Key violations include: 1. Failure to verify finished dietary supplement batches meet product specifications for identity, purity, strength, composition, and contamination limits (21 CFR 111.75(c)). The company's responses were deemed inadequate. 2. Quality control personnel failed to follow written procedures for investigating product complaints (21 CFR 111.103), specifically for complaint records 50638, 50643, 50652, 50656, and 50469. Corrective actions will be evaluated during the next inspection. 3. Failure to verify laboratory examination and testing methodologies are appropriate for intended use (21 CFR 111.320(a)), particularly with FTIR for blends. Responses lacked sufficient evidence of corrective actions. 4. Failure to establish and follow laboratory control processes for selecting standard reference materials (21 CFR 111.