FDA Warning Letter on cGMP Violations of US Based Compounding Facility

A Waring Letter (#659142) issued to a US based compounding facility for several serious cGMP violations, including:

  • The FDA investigators noted serious deficiencies in the practices for producing drug products intended or expected to be sterile, which put patients at risk.
  • The firm did not include the necessary label information of active and inactive materials.
  • The firm did not have an adequate adverse event reporting system.
  • FDA investigators noted that drug products intended or expected to be sterile were prepared, packed, or held under insanitary conditions, whereby they may have become contaminated with filth or rendered injurious to health.
  • Prior to production, non-sterile wipes were used to sanitize surfaces within the ISO 5 aseptic processing area.
  • An operator blocked first air by placing their gloved hands directly over open sterile containers.
  • The firm failed to perform adequate smoke studies under dynamic conditions to demonstrate unidirectional airflow within the ISO 5 area.
  • The firm did not disinfect materials during transfer from the ISO 7 cleanroom into the ISO 5 hood.
  • The firm did not perform adequate product evaluation and take appropriate corrective action after microbial contamination was recovered within the ISO 5 aseptic processing area.

Several other violations were listed for non-HEPA filtered air, lack of validation of aseptic processes, inadequate cleaning and disinfection, issues with facility design, inadequate environmental monitoring, lack of final product testing and an inadequate stability program.

These violations are worrying as they can directly result in the contamination of their products and potential serious health implications for patients.

The company needs to generate a holistic Contamination Control Strategy, analyzing all potential sources of contamination and put mitigation measures in place to protect their patients.


Resource Person: Kieran Falvey, PMP

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