FDA WARNING_LETTER - Nutri-West, Incorporated - April 29, 2011

The FDA conducted an inspection of Nutrition Center, Inc. dba Nutri-West, a dietary supplement manufacturer, from April 25-29, 2011, identifying numerous violations of 21 CFR Part 111, Current Good Manufacturing Practice (CGMP) regulations. Consequently, several of the firm's products were deemed adulterated. Key CGMP deficiencies included failures to establish and include necessary specifications in Master Manufacturing Records (MMRs) and to maintain complete Batch Production Records (BPRs). The firm also failed to conduct identity testing for dietary ingredients, perform finished product testing for identity, purity, strength, and composition, and properly calibrate manufacturing instruments. Additionally, the inspection revealed inadequate measures to prevent foreign material inclusion, and quality control failures regarding component release, supplier qualification documentation, and handling of non-conforming products that failed labeled claims. Furthermore, several products were found to be misbranded under Section 403(q)(5)(F) of the Act due to non-compliant nutrition information presentation on their labels, specifically regarding "Supplement Facts" panel formatting. The firm's initial response to the FDA-483 was deemed inadequate, with unacceptable proposed timeframes for corrections and insufficient documentation. The FDA requires a written response within 15 days detailing specific corrective actions and supporting documentation, warning that failure to comply may result in enforcement actions like product seizure or injunction.