FDA EIR - Stayma Consulting Service, LLC. - November 29, 2016

An FDA inspection of Stayma Consulting Service, LLC, located in Suwanee, GA, was conducted from November 21 to November 29, 2016. This initial inspection was part of the FDA's FY-17 FSMA Non High Risk Inspection Program under the Domestic Food Safety Compliance Program. Stayma Consulting provides services to virtual dietary supplement companies, including linking them to contract manufacturers, developing labels, managing adverse event reporting, and facilitating recalls. The firm does not manufacture, package, hold, or distribute dietary supplements directly.

The inspection involved a facility tour, review of contractual agreements, and examination of supplement labels. While no objectionable conditions leading to an FDA-483 were formally issued, discussions with management highlighted several critical areas. Notably, one product, (b)(4), was launched and marketed as an over-the-counter dietary supplement despite being a prescription-only item, requiring promotion to be halted. General labeling discrepancies were also a point of discussion. The firm’s Senior Vice President of Quality and Regulatory admitted to being less familiar with dietary supplement regulations compared to drug and medical device consulting.

Although no formal regulatory actions were mandated via an FDA-483 due to the firm's consultancy role, management was informed of their ongoing responsibility to ensure labeling compliance and to properly determine if dietary ingredients were new, in accordance with regulatory standards. The FDA referred the firm to its website and 21 CFR 111 for relevant guidance.