Prescription Lab Compounding Pharmacy – FDA 483, Sep 10, 2015

This FDA Form 483 document outlines deficiencies observed during an inspection of a facility involved in preparing sterile drug products. The primary issues identified relate to environmental monitoring and cleaning/disinfection procedures in aseptic processing areas, as well as the validation of sterilization processes for certain products.

Regarding environmental monitoring, the facility's system is deficient as monitoring is not conducted daily when sterile drugs are prepared. Specifically: * Non-viable particulate monitoring in the ISO 5 aseptic processing area and surrounding ISO 7 buffer room is performed every [redacted] by a vendor. * Viable air monitoring in the same areas is performed every [redacted] by a vendor. * Surface monitoring in these areas is performed [redacted]. * Personnel monitoring of gloved fingertips is performed only [redacted].

Aseptic processing areas also show deficiencies in their cleaning and disinfection system. A solution of [redacted] is used to clean the ISO 5 [redacted] and the ISO 7 workbench.

Furthermore, procedures designed to prevent microbiological contamination of sterile drug products lack validation of the sterilization process. Specifically, oil-based products [redacted] have not had their sterilization process [redacted] validated, and no [redacted] are placed in the [redacted] product. An example cited is Testosterone (70/30), Cypion/Enan 200mg/mL, lot number 08212