Multiple Violations at Adept Life Science

A 4/11-4/27/22 FDA inspection at Adept Life Science in Chandler, AZ, found “serious violations” of the Federal Food, Drug, and Cosmetic Act and applicable regulations as they apply to dietary supplements. A 1/24 Warning Letter gives eight examples of current good manufacturing practice (CGMP) violations and four misbranding violations related to labeling of the dietary supplements.

FDA also notes that some of the firm’s products appear to meet the definition of an acidified food or a low-acid canned food and thus the firm may be required to register as a processor of such foods. The letter recommends that Adept work with a process authority to further evaluate its products to establish and file scheduled processes.

Adept was told to respond with a list of specific steps it has taken to correct the violations and prevent their recurrence, with copies of related documentation and a schedule for completing the corrections.