FDA WARNING_LETTER - Talon Compounding Pharmacy - June 29, 2016

An FDA inspection of Talon Compounding Pharmacy from June 21-29, 2016, revealed serious deficiencies in sterile drug product production and failure to meet Section 503A of the FDCA. The firm voluntarily recalled HCG and sermorelin due to sterility assurance issues.

Violations included compounding without valid patient-specific prescriptions and using bulk drug substances (b)(4) not eligible for 503A exemptions, rendering products unapproved new drugs and misbranded. Insanitary conditions observed included: transferring sterile products into less than ISO 5 air, inadequate cleanroom separation and sealing, improper aseptic technique by operators (e.g., touching gloved hands with bare hands, blocking airflow), using expired disinfectants, lack of sterilization/depyrogenation for glassware, and improper storage of sterile vials.

The FDA cited violations of FDCA sections 501(a)(2)(A) (adulterated drugs due to insanitary conditions), 505(a) and 301(d) (unapproved new drugs), and 502(f)(1) (misbranded drugs due to inadequate directions for use).

While some corrective actions were acknowledged, many were deemed inadequate or lacked sufficient documentation, such as protocols for protecting sterile products during transfer, detailed smoke study reports, and adequate disinfection frequencies. The FDA emphasized the need for a comprehensive assessment of operations, potentially with a third-party