FDA WARNING_LETTER - CMC Enterprise Pharmacy - March 22, 2019

On June 4, 2020, the FDA issued a Warning Letter to CMC Enterprise Pharmacy following an inspection from March 18-22, 2019, which revealed serious deficiencies in sterile drug production. The firm received a Form FDA 483 on March 22, 2019, and responded on April 5, 2019. CMC Enterprise Pharmacy voluntarily ceased production of sterile and non-sterile drugs on April 11, 2019, and initiated a recall of all in-expiry sterile drug products.

The FDA found that drug products intended to be sterile were prepared, packed, or held under insanitary conditions, rendering them adulterated under section 501(a)(2)(A) of the FDCA. Violations included: non-laminar airflow, un-evaluated HEPA filters, dirty and particle-generating surfaces in the ISO 5 IV room, inadequate sporicidal agent use, improper personnel gowning and aseptic technique (exposed skin/hair, blocking first air, rapid movement, touching gowns with sterile gloves), poor facility design for material/personnel flow, inadequate material disinfection, lack of controls to prevent lower quality air influx, media fills not performed under challenging conditions, and surface sampling conducted post-cleaning, yielding unrepresentative results.

The FDA acknowledged the firm's cessation of operations as addressing immediate concerns. If CMC Enterprise Pharmacy resumes sterile drug production,