FDA 483 - RC Outsourcing, LLC - February 09, 2016

The FDA Form 483 inspection revealed multiple deficiencies at an outsourcing facility manufacturing sterile and pyrogen-free drug products.

**Key Violations and Observations:**

* **Sterility Testing:** Each batch of injectable product is not tested for endotoxin, failing to confirm conformance to pyrogen-free requirements. * **Aseptic Processing & Contamination Control:** * Media fill procedures (SOP P1.1.2.3) were not fully followed, specifically, a media fill challenge was incomplete during the last attempt. * Differential pressure readings in aseptic processing areas were not monitored frequently or recorded. * **Quality System & Investigations:** * Unexplained discrepancies were not thoroughly reviewed. Investigations into microbial counts exceeding environmental and personnel monitoring alert levels (e.g., 8 CFUs for a redacted sample on 12/4/15) were not documented. * Procedures to investigate deviations from specified temperature and humidity ranges were absent. Deviations in humidity for the label room, anteroom, and clean room were noted but not investigated. * **Facility Construction:** Gaps of approximately 1 inch were present at the bottom of doors leading from a redacted room to the anteroom and from the anteroom to the clean room, hindering proper operations and cleaning. * **Complaint Handling:** Complaint files were not maintained. * **Equipment Calibration:** Routine calibration of the