FDA 483 - Tri-Med, Inc. dba Advanced Care Infusion-Shelby - February 23, 2015

This FDA Form 483 document outlines several deficiencies observed during an inspection of a facility involved in aseptic processing of sterile drug products.

**Key Observations:**

* **Inadequate Investigations:** For multiple discrepancies and out-of-specification results, investigations were deemed inadequate due to the lack of immediate remediation and/or appropriate corrective actions. * **Aseptic Process Simulations (Media Fills):** The facility failed to perform adequate aseptic process simulations (media fills) under representative worst-case aseptic processing conditions, which is critical for assuring the sterility of drug products. * **Cleaning and Sanitization:** Cleaning and sanitization activities in aseptic processing areas were found to be inadequate. * **Environmental Monitoring:** The active viable environmental monitoring (EM) program at the facility was deemed inadequate. * **Facility Design Deficiencies:** Aseptic processing areas exhibited deficiencies in their physical design, specifically that floors, walls, and ceilings did not consist of smooth, easily cleanable surfaces. * **Air Filtration and Pressure:** Aseptic processing areas were deficient regarding air supply, as it was not consistently filtered through high-efficiency particulate air filters under positive pressure. * **Personnel Gowning:** The gowning procedures for personnel performing aseptic operations were found to be inadequate. * **Sterility Testing:** Not all lots of sterile product aseptically processed were tested for sterility.

These observations indicate significant issues within the facility's quality system