FDA WARNING_LETTER - SKNV - July 15, 2016

The FDA issued a Warning Letter to Sincerus Florida, LLC, an outsourcing facility registered under section 503B of the FDCA, following an inspection from July 12-15, 2016. The inspection revealed the facility failed to meet the conditions for 503B exemptions, primarily because it was not engaged in compounding sterile drugs, producing only non-sterile products since its March 2016 registration. Key violations include the failure to submit an initial 6-month drug product report as required by section 503B(b)(2) of the FDCA. Additionally, several drug products had deficient labeling, missing critical information such as the compounded date, dosage form, storage conditions, inactive ingredients list, and the "Office Use Only" statement, violating section 503B(a)(10)(A). Consequently, the firm's drug products are considered unapproved new drugs under sections 301(d) and 505(a) of the FDCA, as no FDA-approved applications are on file. Furthermore, the products are misbranded under section 502(f)(1) of the FDCA because their labeling lacks adequate directions for use, as they are not amenable to self-diagnosis and treatment. The FDA acknowledged the firm's corrective actions for labeling but stressed the fundamental requirement of sterile drug compounding to qualify as an outsourcing facility. The company must promptly correct all violations, investigate their causes, and prevent recurrence. Failure to do so may lead to legal action, including seizure and injunction. A written response detailing corrective actions and timelines is required within fifteen working days.