Caribe Natural LLC – FDA Warning Letter, Nov 23, 2011

On May 14, 2012, the FDA issued a Warning Letter to Caribe Natural LLC following an inspection from September 6 to November 23, 2011. The firm, an own-label distributor of GERMA® brand dietary supplements, was deemed a manufacturer with ultimate responsibility for products introduced into interstate commerce.

The inspection revealed serious violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 111), rendering their dietary supplement products adulterated. Specific CGMP violations included failure to: 1. Make and keep written procedures for quality control operations, particularly regarding material review, disposition of returned products, and approval/release of packaged dietary supplements. 2. Make and keep written procedures for product complaints, including investigation and quality control involvement. 3. Hold components and dietary supplements under appropriate temperature, humidity, and light conditions, and establish/follow written procedures for holding and distribution. 4. Make and keep written procedures for returned dietary supplements, including identification, quarantine, material review, disposition, and salvaging. 5. Establish written procedures for holding and distributing operations, specifically regarding preventing mix-up, contamination, or deterioration. 6. Establish specifications for any point in the manufacturing process to ensure quality and proper packaging/labeling. 7. Establish specifications for each component used in manufacturing. 8. Prepare and follow a written master manufacturing record for each unique formulation and batch size.

Additionally,