FDA WARNING_LETTER - Johnson Memorial Cancer Center - August 05, 2014

On October 28, 2015, the FDA issued a Warning Letter to Johnson Memorial Cancer Center following an inspection from July 16 to August 5, 2014. The inspection revealed serious deficiencies in sterile drug production, posing patient risks.

Violations included insanitary conditions like filth, chipping paint, water stains, and unsealed openings in ISO 7 classified areas, allowing non-HEPA filtered air entry. Dirty equipment, including yellow-discolored HEPA filters, was observed without corrective action. Environmental monitoring was deficient, lacking microbial identification, testing within ISO 5 hoods, and adequate differential pressure monitoring. The firm recovered 55 mold environmental monitoring results (1 cfu and above) from ISO 7 areas but lacked health hazard evaluations. Personnel monitoring was limited to pharmacy technicians' fingers, sampled on an (b)(4) basis, providing no assurance of consistent hygiene.

These conditions led to adulteration charges under Section 501(a)(2)(A) of the FDCA, as products were prepared, packed, or held under insanitary conditions, potentially becoming contaminated. The letter notes the firm ceased on-site sterile drug production on July 8, 2014, and transferred patient treatment to its main hospital. However, the firm's August 21, 2014, response to the FDA-483 indicated an intent to resume production.

The FDA strongly recommends