Soma Labs, Inc. – FDA Warning Letter, Jul 8, 2010

On June 28-July 8, 2010, the FDA inspected Soma Labs, Inc.'s dietary supplement manufacturing facility in Middlesex, NJ, revealing serious violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 111). These violations render the company's dietary supplement products adulterated under section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act.

The primary violation identified was the failure to determine if finished batches of dietary supplements met established product specifications for purity, strength, and composition, as required by 21 CFR 111.73. The company's SOP 21.07 required testing, but no testing was conducted for specific finished lots of (b)(4) capsules, (b)(4) tablets, (b)(4) capsules, (b)(4) tablets, and (b)(4) tablets. Additionally, Soma Labs failed to identify a subset of finished batches using a sound statistical sampling plan to verify product specifications, as required by 21 CFR 111.75(c), lacking documentation for their "(b)(4)" testing practice.

Soma Labs' August 18, 2010, response to the FDA-483 was deemed inadequate. Their statement that testing would be performed, but a note made if no method was available, did not satisfy 21 CFR