FDA EIR - Cosmax Nbt Usa, Inc. - November 22, 2019

A U.S. Food and Drug Administration (FDA) inspection of Cosmax NBT, a dietary supplement contract manufacturer in Garland, TX, was conducted from November 18 to November 22, 2019. The inspection assessed the firm's adherence to relevant Good Manufacturing Practices (GMP) regulations for dietary supplements, specifically compliance program 7321.008.

The inspection identified significant deviations, leading to a 15-item FDA Form 483. Key issues included systemic quality control failures, such as releasing dietary supplement batches that did not meet established product specifications and failing to reject components that did not meet their own specifications. The company also failed to perform appropriate identity testing for dietary ingredients, did not use scientifically valid testing methods, and lacked established specifications for finished product strength and component contamination. Furthermore, original records were not maintained, batch production records were incomplete, and quality control procedures were not consistently followed. Insufficient controls for automated equipment and a lack of review for required test results were also noted. A verbal observation highlighted that the firm's cannabidiol (CBD) products did not meet the definition of a dietary ingredient.

Cosmax NBT management committed to correcting these observations and providing a written response to the FDA within 15 business days.