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Regulatory Focus™ > News Articles > FDA Warns Cancer Center Over Unsanitary Conditions

FDA Warns Cancer Center Over Unsanitary Conditions

Posted 11 November 2015 | By Michael Mezher 

FDA Warns Cancer Center Over Unsanitary Conditions

The US Food and Drug Administration (FDA) has warned the Connecticut-based Johnson Memorial Cancer Center over unsanitary conditions in areas where the center prepares sterile drugs.

The warning comes more than a year after FDA inspectors visited Johnson Memorial's Enfield, Connecticut site from 16 July 2014 and 5 August 2014. During their inspection, FDA found "serious deficiencies" in the center's practices for producing compounded sterile drugs.

The letter lists six deficiencies uncovered at Johnson Memorial that could have caused the compounded drugs produced at its facility to "become contaminated with filth or rendered injurious to health."

Among the issues noted by FDA were:

  1. "55 environmental monitoring reports of mold, 1 CFU [colony forming unit] and above, from classified ISO 7 areas"
  2. "filth, chipped paint, water stains and unsealed openings in the ceiling drop tiles of your ISO-classified rooms"
  3. lack of evidence demonstrating environmental monitoring was performed for ISO 5 hoods where drugs intended to be sterile were produced.
  4. "pressure differentials between the anteroom and the uncontrolled office space were minimal, which creates the risk of dirtier air mixing with cleaner air"
  5. "no assurance that hygiene practices were consistently suitable to prevent microbial contamination"
  6. "dirty equipment … yellow discoloration on the chemotherapeutic room's HEPA filters"

The inspection came just eight days after Johnson Memorial stopped producing sterile drugs on-site. Johnson Memorial also told FDA it would "voluntarily transfer all patient treatment activities to [its] main hospital," which was not subject to the inspection.

Following the inspection, FDA issued Johnson Memorial a Form 483 detailing the issues its investigators identified. According to FDA, Johnson Memorial's response to the 483 indicated that the center planned to resume production after correcting the issues listed in the inspection report.

FDA says it "strongly recommends that [Johnson Memorial] management immediately undertake a comprehensive assessment of [its] operations, including facility design, procedures, personnel, processes, materials, and systems," before resuming production of any sterile drugs.

Warning Letter

Form 483

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