FDA WARNING_LETTER - ForMor, Inc. d/b/a ForMor International - April 04, 2012

On March 30-April 4, 2012, the FDA inspected ForMor Inc. and found serious violations of dietary supplement Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 111). ForMor International contracts with other manufacturers for its dietary supplements, but FDA considers ForMor responsible for labeling operations due to its approval of final label design and content.

Violations include: 1. Failure to implement a system of production and process controls for labeling (21 CFR 111.55). 2. Failure to establish specifications for labeling, including label specifications and specifications for finished product labeling (21 CFR 111.70(a), (d), (g)). 3. Quality control personnel failed to ensure labeling operations comply with CGMP, including reviewing receiving records for labels, approving master manufacturing and batch production records for labeling, performing quality control for labeling, and maintaining required records (21 CFR 111.105, 111.120, 111.123(a)(1), (2), 111.127, 111.140).

As a result, Cardio Cocktail and Argenix dietary supplements are adulterated under 21 U.S.C. § 342(g)(1).

Additionally, the Calm Cocktail product is promoted with