FDA 483 - Edge Pharma, LLC - March 08, 2018

This FDA Form 483, issued to Edge Pharmacy Services, LLC, an outsourcing facility at 856 Hercules Dr, Colchester, VT, on March 8, 2018, details 14 observations from an inspection conducted from February 15 to March 8, 2018.

Key deficiencies include:

**Aseptic Processing & Environmental Monitoring:** * Inadequate environmental monitoring in ISO 5 areas: no viable/non-viable air particle monitoring per product, insufficient procedures (frequency, time, personnel), and release of products (e.g., Avastin, Triamcinolone) without non-viable air sampling. * Surface sampling in ISO 5 not performed per product, and not prior to disinfection between different products. * Inconsistent finger plating of operators (not prior to leaving cleanroom, not daily for gowns). * Failure to perform smoke studies under dynamic conditions for all ISO 5 tables, a repeat observation. * Use of expired media plates for personnel monitoring, leading to product release (e.g., Avastin, Potassium Phosphate) based on invalid data. * Uncalibrated pressure gauge and lack of alarms for pressure differentials between ISO 8 anteroom and unclassified areas.

**Cleaning & Disinfection:** * Improper disinfection practices, such as using one side of a single sterile wipe for multiple surfaces/items. *