FDA WARNING_LETTER - PharmScript, LLC - October 24, 2016

From October 4-24, 2016, FDA inspected PharmScript LLC, identifying serious deficiencies in sterile drug production, leading to adulterated drug products under FDCA Section 501(a)(2)(A). Violations included a deficient facility design where aseptic processing occurred in an unclassified room, and sterile drug production continued for five days with a critical pressure reading of "0.00." The firm also failed to use a sporicidal agent or sterile wipes, instead using a non-sterile disinfectant, and could not demonstrate adequate protection of the ISO 5 classified area.

PharmScript voluntarily suspended IV dispensing on October 1, 2016. While some corrective actions were acknowledged, FDA found them inadequate due to insufficient documentation, specifically regarding facility modifications, the sterility of cleaning agents, and the completeness of smoke studies. FDA strongly recommended a comprehensive assessment of operations by a third-party consultant if sterile drug production resumes.

The letter emphasized that these violations were not exhaustive and required prompt correction to avoid legal action, including seizure and injunction. PharmScript must respond within fifteen working days, detailing corrective actions or confirming non-resumption of sterile drug production. If resuming, a 15-day prior notification is required with an explanation of preventative measures.