FDA WARNING_LETTER - Fragrance Manufacturing, Inc. D/b/a FMI - April 02, 2014

The FDA inspected Fragrance Manufacturing Incorporated DBA FMI's facility from March 20 to April 2, 2014, identifying serious violations of the Federal Food, Drug, and Cosmetic Act.

The "Maty's All Natural Cough Syrup" and "Maty's All Natural Cough Syrup for Kids" products are deemed unapproved new drugs under Section 201(g)(1)(B) and 201(p) of the Act due to therapeutic claims on their labeling, such as "cough syrup," indicating intent for disease treatment. Introducing these products into interstate commerce without FDA approval violates Sections 505(a) and 301(d).

Additionally, these products are adulterated under Section 402(g)(1) due to non-compliance with dietary supplement Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 111). Specific violations include: 1. Failure to establish product specifications for identity, purity, strength, composition, and contamination limits for finished batches (21 CFR 111.70(e)), specifically for zinc gluconate strength and yeast/mold plate counts. The company's response lacked documentation for newly established specifications. 2. Failure to provide adequate documentation for determining that microbial limits ensure finished product quality (21 CFR 111.75(c)(3)). The response lacked scientific rationale for safe