Axium Healthcare Pharmacy dba Balanced Solutions Compounding – FDA Warning Letter, Mar 15, 2013

On July 16, 2013, the FDA issued a Warning Letter to Axium Healthcare Pharmacy, Inc. dba Balanced Solutions Compounding Pharmacy, following an inspection from March 12-15, 2013. The inspection revealed the firm was producing a significant number of drug products without valid prescriptions for individually-identified patients, and observed serious deficiencies in sterile drug product manufacturing practices, leading to two contaminated product recalls.

Violations included microbial contamination in Chromium Chloride Injection and black particles in Triamcinolone Acetonide. The firm's aseptic processing area lacked a unidirectional flow hood, using an inadequate HEPA filter. Technicians wore non-sterile gowns, exposed bare skin, extended arms over sterile vials, and moved improperly in aseptic areas.

These issues mean the drugs do not qualify for exemptions under FDCA section 503A or FDA's Compliance Policy Guide 460.200. Consequently, drugs produced without individual prescriptions are unapproved new drugs (violating sections 505(a) and 502(f)(1) of the FDCA) and misbranded. Sterile products are adulterated under section 501(a)(2)(A) due to insanitary conditions. Furthermore, the firm is subject to CGMP regulations (21 CFR Parts 210 and 211), with observed violations including failure to reject non-conforming products, inadequate