FDA WARNING_LETTER - Wells Pharmacy Network LLC - June 19, 2014

The FDA issued a Warning Letter to Wells Pharmacy Network, LLC, following inspections from July 2013 to June 2014, identifying significant violations. The firm was found to be producing drug products without valid prescriptions for individually-identified patients, rendering these drugs unapproved new drugs and misbranded under sections 505(a) and 502(f)(1) of the FDCA.

Furthermore, serious deficiencies in sterile drug product manufacturing practices were observed, leading to adulteration charges under section 501(a)(2)(A) and 501(a)(2)(B) of the FDCA. Violations included technicians wearing non-sterile gowns during aseptic operations, failure to use sporicidal agents in ISO-5 areas, use of non-pharmaceutical grade materials for sterilization without proper testing, and inadequate environmental monitoring. The firm also failed to establish appropriate written procedures for preventing microbiological contamination, assessing drug product stability, cleaning and disinfecting aseptic areas, and ensuring personnel wear appropriate clothing.

The FDA emphasized that the firm's operations are subject to Current Good Manufacturing Practice (CGMP) regulations (21 CFR Parts 210 and 211) due to compounding without patient-specific prescriptions. The letter requires immediate corrective actions, including a comprehensive assessment of manufacturing operations, potentially with a third-party consultant. Failure to correct these violations may result in legal action, including seizure and injunction. A written response