Sincerus Florida, LLC dba SKNV – FDA 483, Jul 15, 2016

On July 15, 2016, the FDA issued a Form 483 to Sincerus Florida LLC, an outsourcing facility located at 3265 W McNab Road, Pompano Beach, FL 33069. The inspection, conducted from July 12-15, 2016, identified a violation concerning drug product labeling.

The observation states that labels for the outsourcing facility's drug products do not include information required by section 503B(a)(10)(A) of the Federal Food, Drug, and Cosmetic Act. Specifically, the date the drug was compounded, dosage form, storage and handling conditions, list of inactive ingredients, and the statement "Office use only" are missing from drug product labels.

Examples of affected products include: 1. ROSACEA SILICONE GEL (IVERMECTIN 1% / METRONIDAZOLE 1% / NIACINAMIDE 4% / POTASSIUM AZELOYL DIGLYCINATE 5%), lot PC051716MNP 2. ANTI-FUNGAL NAIL SOLUTION 15ML (FLUCONAZOLE 4% / IBUPROFEN 2% / ITRACONAZOLE 1% / TERBINAFINE 4%), lot PC061416FUT 3. ROSACEA SILICONE