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

The FDA conducted an inspection of RTI Biologics, Inc. from June 25 to July 11, 2012, identifying significant deviations from HCT/P regulations (21 CFR Part 1271).

Key violations include: 1. **Failure to prevent communicable disease transmission (21 CFR 1271.145):** * From Jan 2011 to June 2012, finished product packaging swab cultures and D-test cultures of Sports Medicine products frequently detected *Pseudomonas* species (70 occasions, including *P. aeruginosa*), *Serratia liquefaciens*, fungus, *Bacillus* species, and yeast. * Aseptically-processed Bio DBM boats also showed *Bacillus* species, coagulase negative *Staphylococcus*, and fungus in D-test cultures. * BioCleanse bioburden monitoring samples had elevated CFU counts for aerobes and fungi, including *Pseudomonas fluorescens*, not identified in pre-processing cultures.

2. **Failure to control environmental conditions (21 CFR 1271.195(a)):** * Gram negative organisms and fungus were recovered during environmental monitoring of the Class 5 processing/packaging area. * *Pseudomonas* species were detected in both RTI West and RTI East water systems, used for