FDA WARNING_LETTER - Health Breakthrough International, LLC - April 18, 2013

The FDA issued a Warning Letter to Health Breakthroughs International, LLC following an inspection on April 12, 16, and 18, 2013. The inspection revealed significant violations of current Good Manufacturing Practice (CGMP) regulations for dietary supplements (21 CFR Part 111), causing products like MPS Gold 100, MPS Gold 3X, and Amazing C to be adulterated. Additionally, MPS Gold 100 and MPS Gold 3X were found to be misbranded under 21 CFR Part 101.

CGMP violations included failures to verify dietary ingredient identity, qualify suppliers, establish component, label, and packaging specifications, and determine if finished products met specifications. The firm lacked established and followed Master Manufacturing Records and failed to prepare complete Batch Production Records, missing critical details. Quality control operations were not properly implemented, qualified personnel were not identified, and written QC procedures were absent. Further issues involved not collecting reserve samples, failing to quarantine components, and lacking written procedures for equipment calibration. Misbranding violations included not identifying the plant part for botanical ingredients on labels and omitting "net weight" or "net wt." from product labels. The firm's lot code system was also inconsistent. The FDA requires prompt corrective actions within 15 working days, warning that failure to comply may lead to enforcement actions like seizure or injunction, and re-inspection fees.