Lack of Sterility Assurance – Ranier’s Pharmacy

On July 10, 2018 FDA issued a health care alert for products compounded by Ranier’s Pharmacy do to a lack of sterility assurance. Rainer’s inspection history includes:

  • A 6-page form 483 issued April 22, 2016
  • A warning letter issue March 28, 2017 (for the inspection April 18-22, 2016)
  • A 5-page form 483 issued May 22, 2018 (following an inspection from May 14-22, 2018)

In the warning letter, the FDA recommended:

FDA strongly recommends that your management first undertake a comprehensive assessment of operations, including facility design, procedures, personnel, processes, materials, and systems for the production of human and animal drugs.  In particular, this review should assess your aseptic processing operations.  A third party consultant with relevant sterile drug processing expertise could be useful in conducting this comprehensive evaluation.

The most recent inspection, 9-observations that have a potential negative impact on aseptic processing were observed.  These conditions included:

  • Personnel touched equipment or other surfaces located outside of the ISO 5 classified aseptic processing area with gloved hands and then engaged in aseptic processing without changing or sanitizing gloves.
  • Personnel engaged in aseptic processing were observed with exposed hair.
  • Equipment was and Materials or supplies were not disinfected prior to entering the aseptic processing areas.
  • The use of sporicidal agents in the ISO 5 classified aseptic processing area was inadequate based on specified concentration and contact time.
  • Disinfecting agents and cleaning wipes used in the ISO 5 classified aseptic processing areas were not sterile.
  • Your facility was designed and/or operated in a way that permits poor flow of personnel and materials.
  • Non-microbial contamination was observed in your production area.
  • Procedures designed to identify and prevent insanitary conditions are not established and followed by your firm.
  • The ISO 5 classified aseptic processing areas and segregated production areas surrounding the ISO 5 classified aseptic processing area contained dust-collecting overhangs without adequate and frequent cleaning.

On June 6, 2018, FDA recommended that Ranier’s Compounding recall all unexpired human and animal drug products intended to be sterile and to cease sterile operations until it makes adequate corrections at its facility.  On June 7, 2018, Ranier’s Pharmacy informed FDA that it agreed to voluntarily recall and cease sterile operations. However, the company has failed to comply with this commitment and on July 10, FDA issued the health care alert.

As an outside observer (with only the information publically available) my thoughts on the sequence of events.  The firm was inspected in April of 2016 with a “Producer of Sterile Drugs” as the establishment type inspected.  There were several issues related to lack of sterility assurance identified during this inspection.  Apparently not corrected as a warning letter was issued in March which identified 4 corrective actions which the FDA were not able to evaluate based on lack of supporting documentation and an additional 4 corrective actions that appeared inadequate.  Apparently these conditions were still not corrected as similar issues leading to a lack of sterility assurance were identified in the 2018 inspection. The firm agrees to recall products and cease sterile operations with the FDA –  but failes to do so.  You do not make commitments to the agency who regulates your business – then decide not to follow through. In other words, you don’t poke the bear.