Accurate RX Pharmacy Consulting LLC – FDA Warning Letter, Sep 19, 2018

On September 2, 2020, the FDA issued Warning Letter #604449 to Accurate Rx Pharmacy Consulting LLC dba Accurate Rx Pharmacy, following an inspection from September 10-19, 2018. The inspection revealed serious deficiencies in the production of sterile drug products, rendering them adulterated under Section 501(a)(2)(A) of the FDCA due to insanitary conditions.

Key violations include: 1. **Facility Design:** An ISO5-classified workstation, used for sterile drug production, was located and operated in a non-classified area. A ductless air conditioning unit, mounted directly above the ISO5 workstation in the non-classified room, circulated non-HEPA filtered air, posing a direct contamination risk. 2. **Cleaning and Disinfection:** Non-sterile wipes and cleaning agents were used in the ISO5 area, potentially introducing microbial contamination. A sporicidal cleaning agent was not used. 3. **Environmental Monitoring (EM):** EM samples were collected after cleaning, not representing actual environmental conditions.

The FDA reviewed the firm's October 2, 2018, response but found proposed corrective actions deficient. For instance, the firm's intent to (b)(4) during cleaning did not mitigate the fundamental contamination risk of operating an ISO5 workstation in a non-classified area. Similarly, maintenance procedures for the AC unit were