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 21-29, 2016. This initial inspection was part of the Domestic Food Safety Compliance Program (CP 7303.803), focusing on non-high-risk food safety. Stayma Consulting provides various services to virtual dietary supplement companies, including connecting them with contract manufacturers, developing labels, managing complaints and adverse event reporting, and facilitating product recalls. The inspection confirmed that Stayma does not manufacture, package, or hold dietary supplements on-site. However, they are responsible for critical functions such as coordinating recalls, initiating adverse event reports, investigating complaints, and developing product labeling. A significant issue identified involved a prenatal vitamin product incorrectly marketed as an over-the-counter dietary supplement when it required a prescription. While no formal FDA-483 observation form was issued, as the firm is a consultancy and no physical manufacturing violations were found, management was advised about their responsibility to ensure product labeling compliance and to correctly determine if dietary ingredients are "new" according to agency standards, referring them to 21 CFR 111 and FDA guidance documents. The firm's Senior Vice President of Quality and Regulatory admitted unfamiliarity with dietary supplement regulations.