FDA 483 - RTI Surgical, Inc. dba RTI Biologics, Inc. - July 11, 2012

The FDA inspected RTI Biologics, Inc., a human tissue and medical device manufacturer in Alachua, FL, from June 25 to July 11, 2012. The inspection revealed six observations regarding environmental controls, corrective actions, process validation, and prevention of communicable disease transmission.

Observation 1 noted inadequate environmental control, with gram-negative organisms and fungus recovered from Class 5 processing/packaging areas and Pseudomonas species from the water system used for manufacturing and cleaning. Black sprayers cleaned with this water also tested positive for Pseudomonas.

Observation 2 stated that environmental controls did not provide for adequate cleaning and disinfecting of rooms and equipment for aseptic processing, specifically noting a change in cleaning contractors.

Observation 3 highlighted that corrective actions for core CGTP requirements were insufficient, lacking both short-term and long-term solutions. Issues included unaddressed potential contamination effects on the validated sterilization process, continued sporadic failures of "Bio DBM boats" despite corrective actions, unidentified gram-negative rods in the Class 5 Deval area, delayed investigations into Pseudomonas contamination, and inadequate corrective actions for failed soft tissue final release testing.

Observation 4 indicated that processes, specifically for fresh osteochondral (OC) allografts, were not validated and approved according to established procedures.

Observation 5 found that temperature and humidity were not adequately controlled in classified core areas where tissue processing and final packaging occur.

Observation 6 cited a failure to process and package