FDA WARNING_LETTER - Nutrafill, LLC - June 04, 2015

The FDA inspected a dietary supplement manufacturing facility from June 1-4, 2015, and reviewed product labels, identifying serious violations of the Federal Food, Drug, and Cosmetic Act. The firm's June 16, 2015, response was inadequate, lacking documentation for corrective actions. "Natural Solutions Manganese Plus" was cited as an unapproved new drug due to therapeutic claims (e.g., "powerful anti-inflammatory") indicating intent for disease treatment, making it not generally recognized as safe and effective. Several products were deemed adulterated under 21 CFR Part 111 due to cGMP violations. These included failures to establish written quality control procedures, specifications for components, in-process, labels, packaging, and finished products, and to maintain complete Master Manufacturing Records and Batch Production Records. The firm also lacked effective measures to prevent foreign material contamination. Products were also misbranded under section 403 of the Act due to labeling deficiencies. These included unlisted capsule ingredients, incorrect serving sizes, improper nutrition information presentation, and failure to identify botanical plant parts. Other issues noted were missing specific constituents for standardized ingredients, misspelled ingredients, and incomplete manufacturer/distributor information (21 CFR 101.5). The FDA mandates prompt corrective action and preventative procedures, requiring a written response with documentation within fifteen working days. Non-compliance could lead to regulatory actions like seizure or injunction, and reinspection fees.