FDA WARNING_LETTER - Swedish Bitters Herbs Company - July 14, 2010

The FDA issued a Warning Letter to Swedish Bitters Herbs Company following an inspection from July 6-14, 2010, at their Concordia, Missouri facility, which manufactures, packages, labels, and holds dietary supplements. The inspection revealed multiple violations of 21 CFR Part 111, Current Good Manufacturing Practice (CGMP) for dietary supplements, rendering their products adulterated under Section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act).

Key violations include: 1. Failure to conduct identity testing for dietary ingredients prior to use (21 CFR 111.75(a)(1)(i)). 2. Failure to determine if finished product specifications for identity, purity, strength, and composition were met (21 CFR 111.73, 111.75(c)). 3. Failure to prepare and follow written master manufacturing records (MMR) for each unique formulation and batch size (21 CFR 111.205(a)). 4. Failure to prepare batch production records for each manufactured batch (21 CFR 111.255(a)). 5. Failure to establish and follow written procedures for quality control operations (21 CFR 111.103). 6. Failure to maintain, clean, and sanitize equipment and utensils,