FDA WARNING_LETTER - Pharmacy Resources Incorporated - May 23, 2017

The FDA issued a Warning Letter to Pharmacy Resources, Inc. following a May 8-23, 2017, inspection that revealed serious deficiencies in sterile drug product production and non-compliance with the Federal Food, Drug, and Cosmetic Act (FDCA). The firm failed to meet Section 503A conditions by not receiving valid prescriptions for individually-identified patients for a portion of its compounded drug products. Consequently, these "ineligible drug products" are not exempt from FDA approval, adequate directions for use, and Current Good Manufacturing Practice (CGMP) requirements.

The inspection found drug products adulterated under FDCA Section 501(a)(2)(A) due to insanitary conditions, including inadequate contact times for sporicidal agents and insufficient dynamic smoke studies in the aseptic processing area. Furthermore, the ineligible drug products were adulterated under Section 501(a)(2)(B) due to significant CGMP violations (21 CFR Parts 210 and 211). These included failures to establish adequate cleaning/disinfection systems, environmental monitoring, written procedures to prevent microbiological contamination, proper personnel gowning, scientifically sound laboratory controls, stability testing programs, and routine equipment calibration. The ineligible drug products were also deemed misbranded under FDCA Section 502(f)(1) because their labeling lacked adequate directions for use.

The FDA reviewed the firm's June 8, 2017, response but found several corrective actions inadequate or lacking supporting documentation, particularly concerning sporicidal agent contact times, smoke studies, personnel gowning, and sterility testing. The FDA strongly recommends a comprehensive assessment of operations, including aseptic processing, with assistance from a third-party consultant. The firm must promptly correct all violations within 15 working days, providing detailed explanations and documentation, or face potential legal action, including seizure and injunction.