FDA WARNING_LETTER - One Way Drug, LLC - May 30, 2014

This FDA Warning Letter, dated July 22, 2015, was issued to One Way Drug, LLC dba Partell Specialty Pharmacy following an inspection from May 21-30, 2014. The inspection revealed serious deficiencies in sterile drug product production and non-compliance with federal regulations.

Key violations include: - **Lack of Valid Prescriptions:** The firm produced drug products without valid prescriptions for individually-identified patients, violating Section 503A of the FDCA, rendering these drugs unapproved new drugs and misbranded. - **Insanitary Conditions & Adulteration:** Sterile drug products were prepared under insanitary conditions, leading to adulteration under Section 501(a)(2)(A) of the FDCA. Specific observations included: - Operators stoppering vials with gloved hands on a partially separated table and processing sterile products with exposed skin. - Failure to use sporicidal agents for cleaning production areas. - Infrequent viable and non-viable monitoring. - Lack of continuous pressure differential monitoring. - Transfer of bulk drug product containers into ISO-5 area without sanitization. - Failure to demonstrate adequate protection of the ISO-5 area by the workbench. - **CGMP Violations:** Significant Current Good Manufacturing Practice (CGMP) violations were observed, causing drugs to be adulterated under Section 501(a)(2