Naturavit, Inc. – FDA Warning Letter, Mar 2, 2012

On August 27, 2012, the FDA issued a Warning Letter to Naturavit, Inc., following an inspection from February 27 to March 2, 2012. The inspection revealed serious violations of Current Good Manufacturing Practice (CGMP) for dietary supplements (21 CFR Part 111), rendering their products adulterated under section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act).

Key violations include: - Failure to prepare and follow written master manufacturing records (21 CFR 111.205(a)). - Failure to prepare batch production records (21 CFR 111.255(a)). - Lack of identified quality control personnel and written procedures for quality control operations (21 CFR 111.12(b), 111.103, 111.140(b)(1)). - Failure to conduct appropriate tests or rely on qualified certificates of analysis for components (21 CFR 111.75(a)(2)). - Absence of written procedures and records for labeling operations (21 CFR 111.430(b)). - Failure to make and keep written procedures and records for holding and distributing operations (21 CFR 111.475(b)). - Lack of written procedures