FDA WARNING_LETTER - NatureMost of New England, Inc. - October 12, 2011

On September 22, 2011, through October 12, 2011, the FDA inspected NatureMost of New England, Inc. in Middletown, CT, identifying significant violations of Current Good Manufacturing Practice (CGMP) regulations for dietary supplements (21 CFR Part 111). This caused their C-Complex 1150 mg dietary supplement to be adulterated under section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act).

Key violations include: - Failure to conduct identity testing for dietary ingredients (e.g., ascorbic acid) before use, relying solely on supplier Certificates of Analysis, which is not permitted for dietary ingredients (21 CFR 111.75(a)(1)(i)). - Failure to establish component specifications for identity, purity, strength, and composition (21 CFR 111.70(b)), and product specifications for contamination limits (21 CFR 111.70(e)). - Failure to verify finished product specifications for identity, purity, strength, and composition through testing (21 CFR 111.75(c)). - Incomplete batch production records (BPRs) lacking information on equipment maintenance, finished product documentation, packaging/labeling operations, material review, and reprocessing (21 CFR 111.255(b),