FDA WARNING_LETTER - Pharmagen Laboratories, Inc - August 23, 2013

This FDA Warning Letter, CMS # 435786, dated October 24, 2014, addresses Pharmagen, Inc. following an inspection from August 5 to August 23, 2013, at their Stamford, CT facility. The inspection revealed serious deficiencies in sterile drug product production.

Key violations include: - **Aseptic Technique Deficiencies:** Operators did not use proper aseptic technique for sterile gowning (e.g., no gloves, no sleeve covers) and leaned on aseptic work surfaces. - **Environmental Control:** Failure to demonstrate adequate protection of ISO 5 areas by hoods, posing a significant contamination risk. - **Unapproved New Drugs/Misbranding:** Prior to registering as a 503B outsourcing facility, Pharmagen produced drugs without valid prescriptions for individually-identified patients, rendering them unapproved new drugs (violating FDCA section 505(a)) and misbranded due to inadequate directions for use (violating section 502(f)(1)). - **Insanitary Conditions:** Sterile drug products were prepared, packed, or held under insanitary conditions, causing them to be adulterated (violating section 501(a)(2)(A)). - **CGMP Violations:** Significant Current Good Manufacturing Practice (CGMP) violations were observed, causing drug products to be adulterated (violating section 501(a