FDA WARNING_LETTER - RC Outsourcing LLC - March 31, 2017

RC Outsourcing, LLC, an FDA-registered outsourcing facility, was inspected by the FDA from March 27-31, 2017. The inspection revealed serious deficiencies in the firm's practices for producing sterile drug products, leading to a Form FDA 483. The FDA determined that the drug products produced were adulterated under section 501(a)(2)(B) of the FDCA due to current good manufacturing practice (CGMP) violations, specifically citing 21 CFR parts 210 and 211. Key violations included the failure to establish and follow appropriate written procedures to prevent microbiological contamination, including validation of aseptic and sterilization processes (21 CFR 211.113(b)); failure to thoroughly investigate unexplained discrepancies or batch failures (21 CFR 211.192); and failure to establish an adequate system for monitoring environmental conditions in aseptic processing areas (21 CFR 211.42(c)(10)(iv)). The firm's responses to the FDA 483 were deemed deficient, lacking adequate supporting documentation for proposed corrective actions, such as growth promotion testing procedures, complete SOPs for alert/action levels, and comprehensive environmental monitoring (e.g., fingertip monitoring, daily volumetric air sampling). The FDA strongly recommended a comprehensive assessment of operations, including facility design, procedures, personnel, processes, maintenance, materials, and systems, with the assistance of a third-party consultant. The firm must take prompt action to correct these violations within fifteen working days to avoid potential legal action, including seizure and injunction.