FDA 483 - Intrathecal Compounding Specialists, LLC - November 17, 2017

During an FDA inspection, several deficiencies were noted regarding aseptic processing and quality control. The facility failed to adequately evaluate and take remedial action for actionable microbial contamination in the ISO 5 aseptic processing area, specifically when employee fingertip tests repeatedly yielded positive results without microorganism identification, yet sterile drug production and distribution continued. Highly potent drugs were produced without adequate segregation, work surface cleaning, or personnel cleaning to prevent cross-contamination.

Personnel exhibited poor aseptic technique, touching non-ISO 5 surfaces with gloved hands before engaging in aseptic processing without glove changes or sanitization. Improper gowning was observed, including an employee touching the outside of gloves with a bare hand without disinfection before compounding sterile drugs. Exposed hair and mouth were noted in the ISO 5 environment during aseptic operations. Personnel reused fluid-resistant gowns throughout the day, leaving and re-entering cleanrooms from non-classified areas without replacing gowning apparel.

Supplies, materials, and equipment were not disinfected prior to entering ISO 5 and ISO 7 environments. Non-microbial contamination, specifically a brown-stained HEPA filter, was observed in the production area. The ISO 5 area contained difficult-to-clean and particle-generating equipment, evidenced by threads stuck in a laminar flow hood outlet cover. Disinfectant contact times and coverage were insufficient, with employees observed cleaning front to back, reusing wipes, and cleaning during operations with the same portion of a wipe.

ISO-5 classified areas were not certified under