Global Sweet Polyols, LLC – FDA Warning Letter, Jun 10, 2011

On November 18, 2011, the FDA issued a Warning Letter to Global Sweet Polyols, LLC, following an inspection from May 27 to June 10, 2011. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations for dietary supplements (21 CFR Part 111), rendering their Manno Max D-Mannose and GlycoBiotics D-Ribose products adulterated.

Key violations include: 1. Failure to have written master manufacturing records for packaging and labeling operations (21 CFR 111.415). 2. Failure to establish specifications for incoming components (21 CFR 111.70(f)). 3. Failure to maintain written procedures for packaging and labeling operations (21 CFR 111.430(b)). 4. Failure to establish and follow written procedures for quality control operations, including approval/rejection of reprocessed or released products (21 CFR 111.103, 111.127(h)). 5. Failure to establish written procedures for holding and distributing operations, including proper storage conditions and reserve sample retention (21 CFR 111.453). 6. Failure to hold components, dietary supplements, packaging, and labels under conditions preventing mix-up, contamination, or deterioration (2