FDA WARNING_LETTER - Shamrock Medical Solutions Group LLC - October 02, 2009

The FDA issued a Warning Letter to Shamrock Medical Solutions Group following inspections from July to October 2009 at their East Taunton, Massachusetts, pharmaceutical repackaging and relabeling facility. The inspections revealed significant Current Good Manufacturing Practice (CGMP) violations (21 CFR Parts 210 and 211), rendering their drug products adulterated under section 501(a)(2)(B) of the Act. Additionally, the firm was found to be manufacturing and marketing unapproved new drugs (section 505(a)) and misbranded drugs (section 502(f)(1)). Key deficiencies included a lack of written procedures for production and process controls, inadequate investigations into product failures, and improper equipment cleaning, maintenance, construction, and calibration. The firm lacked a written program for stability testing to support assigned expiration dates, using unsupported 12-month dates. The Quality Control unit failed to approve critical procedures, and employees lacked adequate CGMP training. The FDA noted that the firm's responses were insufficient, lacking supporting documentation and failing to address interim controls or global quality system issues, as similar deficiencies were observed at their Ohio facility in 2007. Shamrock Medical was instructed to promptly correct all violations, discontinue manufacturing unapproved drugs, and update drug listing files. Failure to comply could lead to legal action, including seizure and injunction, and impact export certificates or pending drug applications. A written response detailing corrective actions and timelines is required within fifteen working days.