The QMN Weekly Bulletin
Pharmaceuticals / Inspections and Audits

Seattle Compounder Warned Over Sterility Issues

Aug. 31, 2018

Compounding pharmacy Kelley-Ross & Associates in Seattle drew a warning letter from the FDA after an agency inspection in July found numerous sanitation violations.

The FDA investigator observed several drug product sterility issues, including failure to disinfect materials before placing them in an ISO 5 classified area. The classified area did not undergo smoke studies to show unidirectional airflow, indicating that the facility may not have established adequate safeguards against contaminants.

Some of the pharmacy’s classified areas had visibly dirty equipment and were hard to properly clean, while cracks were seen in a glass window separating ISO 7 classified rooms.

In addition, the firm failed to use a sporicidal agent as part of its cleaning and disinfection program for aseptic processing areas. The investigator also observed white residue on equipment used to produce non-sterile drug products.

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