One Way Drug, LLC dba Partell Specialty Pharmacy – FDA Warning Letter, Mar 8, 2018

This FDA Warning Letter, dated February 4, 2019, addresses One Way Drug LLC, dba Partell Specialty Pharmacy, following inspections of their West facility (July 17-19, 2017) and East facility (February 26-March 8, 2018). The inspections revealed that drug products produced failed to meet Section 503A of the FDCA conditions for exemption from CGMP, adequate labeling, and FDA approval.

Violations included insanitary conditions at both facilities, such as using a vacuum cleaner for a powder press and observing black residue, rust, and mold in the East facility's sterile compounding area. Significant CGMP violations at the West facility included inadequate environmental monitoring, lack of media fills, and insufficient personnel qualification. These issues render the drug products adulterated under sections 501(a)(2)(A) and 501(a)(2)(B) of the FDCA. Additionally, compounded drug products using bulk substances like calendula and comfrey, which lack USP/NF monographs or FDA approval, are misbranded under section 502(f)(1) of the FDCA as they lack adequate directions for use.

Partell Specialty Pharmacy stated they ceased sterile compounding and initiated a voluntary recall. While some corrective actions regarding bulk drug substances were acknowledged, the letter emphasizes that insanitary conditions apply regardless of 503A exemption status.