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

Source: https://www.keypedia.com/records/warning_letter/rti-surgical-inc-dba-rti-biologics-inc/b5ad1ca5-1df5-4296-8e71-6e81d6e6e5c8

> FDA WARNING_LETTER for RTI Surgical, Inc. dba RTI Biologics, Inc. on July 11, 2012. Product: Biologics. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: RTI Surgical, Inc. dba RTI Biologics, Inc.
- Inspection Date: 2012-07-11
- Product Type: Biologics
- Office Name: Department of Health and Human Services
- Summary: 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

## Related Documents

- [483 - 2012-07-11](https://www.keypedia.com/records/483/rti-surgical-inc-dba-rti-biologics-inc/ce391437-3550-4865-9ed2-5ec6976b5be9)
- [WARNING_LETTER - 2017-04-28](https://www.keypedia.com/records/warning_letter/rti-surgical-inc-dba-rti-biologics-inc/2845f3aa-9679-4f58-95f3-6754d8531bea)

## Related Officers

- [District Director](https://www.keypedia.com/people/emma-r-singleton/e0b72aba-caa5-4cf8-8beb-6f93f6654e59)

Company: https://www.keypedia.com/companies/rti-surgical-inc-dba-rti-biologics-inc/ab757bb1-704a-479f-81c8-259248ec1a38

Office: https://www.keypedia.com/offices/department-of-health-and-human-services/cecfcda4-4afa-4a1f-a7b7-a020b79f9861