Valentine Enterprises, Inc. – FDA Warning Letter, Oct 24, 2024

Valentine Enterprises, Inc. received an FDA Warning Letter following an inspection from October 8-24, 2024, at their Lawrenceville, GA facility. The inspection revealed significant violations of the Federal Food, Drug, and Cosmetic Act, resulting in their dietary supplement product, "Vibrant Health Green Vibrance," being deemed adulterated and misbranded.

The core issues stemmed from a failure to comply with Current Good Manufacturing Practice (CGMP) regulations for dietary supplements (21 CFR Part 111). Specifically, the company did not establish adequate product specifications for finished batches, including insufficient identity testing methods and a lack of scientific rationale for testing frequency. They also failed to verify the suitability of third-party laboratory testing methodologies for pathogen detection. Additionally, batch production records for "Vibrant Health Green Vibrance" were incomplete, missing crucial information on equipment maintenance and in-process testing results.

Furthermore, several dietary supplement labels were found to be misbranded under Section 403 of the Act. This included instances where labels failed to declare the common or usual names for all ingredients and presented incorrect serving sizes for various products. Although Valentine Enterprises, Inc. submitted multiple responses with corrective actions, the FDA found them to be largely insufficient or lacking the necessary supporting documentation for thorough evaluation. The company is mandated to implement comprehensive corrective actions addressing all identified CGMP and labeling violations and must provide robust documentation to demonstrate sustained compliance, which the FDA will verify in a subsequent inspection.