FDA WARNING_LETTER - Noven Pharmaceuticals, Inc. - February 14, 2011

An FDA inspection of Noven Pharmaceuticals, Inc. in Carlsbad, California, from January 31 to February 14, 2011, identified significant Current Good Manufacturing Practice (CGMP) violations for Finished Pharmaceuticals, rendering their drug products adulterated under 21 U.S.C. § 351(a)(2)(B). The firm's February 28, 2011, response was deemed inadequate. Key violations included a lack of adequate written procedures for production and process controls (21 C.F.R. § 211.100(a)), specifically concerning inadequate process validation for Fentanyl Transdermal System and the Fentanyl Adhesive Mass Solution mixing process. The firm also failed to ensure equipment performed satisfactorily (21 C.F.R. § 211.68(a)), citing inadequate qualification of a cutting/packing machine and a checkweigher. Furthermore, Noven Pharmaceuticals did not thoroughly investigate unexplained discrepancies or batch failures (21 C.F.R. § 211.192), such as defects in Fentanyl Transdermal System pouches and customer complaints of missing patches. Deficiencies in exercising appropriate controls over computer systems (21 C.F.R § 211.68(b)), particularly regarding server backups, and a failure to determine actual and theoretical yields at appropriate manufacturing phases (21 C.F.R § 211.103) were also cited. The FDA requires prompt corrective actions within fifteen working days, with potential legal action, impact on federal contracts, and withholding of drug approvals if violations are not addressed.