Sincerus Florida, LLC dba SKNV – FDA 483, May 23, 2024

During an inspection conducted from May 13 to May 23, 2024, the U.S. Food and Drug Administration (FDA) issued a Form FDA 483 to SKNV, an outsourcing facility located in Pompano Beach, FL. The inspection identified significant deviations from regulatory requirements concerning drug product labeling and reporting.

Observation 1 cited the company for failing to include essential information on the containers of its drug products, as mandated by section 503B(a)(10)(B) of the Federal Food, Drug, and Cosmetic Act. Specifically, product containers lacked details for adverse event reporting, such as the FDA MedWatch website and phone number, and adequate directions for use, including dosage and administration.

Observation 2 noted that SKNV failed to submit a comprehensive report to the FDA identifying all drugs compounded during the previous six-month period. Several specific products, including various solutions and creams, were compounded but not listed in the December 2023 report.

These observations indicate that SKNV must implement corrective actions to ensure compliance with federal drug regulations, particularly regarding accurate product labeling and complete reporting of compounded drug products. Addressing these issues is crucial for patient safety and regulatory adherence.