FDA 483 - Phase 4 Pharmaceutical Llc - May 02, 2017

Phase 4 Pharmaceutical Llc, a drug repackager and relabeler in Aventura, FL, was inspected by the FDA. The inspection revealed significant deficiencies in written procedures and quality control unit responsibilities for transdermal drug products. These issues indicate a lack of adequate controls over manufacturing, warehousing, distribution, complaint handling, and returned products.