FDA WARNING_LETTER - Bacterin International, Inc. - July 26, 2012

On July 16-26, 2012, an FDA inspection of Bacterin's Belgrade, Montana facility, which manufactures OsteoSelect Demineralized Matrix Bone (DBM) Putty, revealed significant violations of Current Good Manufacturing Practice (CGMP) requirements under the Quality System (QS) regulation (21 CFR Part 820). The device was deemed adulterated and misbranded.

Key violations include: 1. **Failure to establish and maintain CAPA procedures (21 CFR 820.100(a)):** A high-risk mislabeling deviation (DEV11-104) did not result in a CAPA, and corrective actions for CAPA 11-001 (out-of-specification endotoxin results) were not completed before closure. The firm also lacked procedures for trending quality data (deviations, complaints, CAPA). 2. **Failure to maintain complaint files and procedures (21 CFR 820.198(a)):** Two DBM Putty complaints lacked MDR reportability evaluations, and the complaint form/SOP did not include procedures for documenting MDR reportability. 3. **Failure to establish and maintain procedures for changes (21 CFR 820.70(b)):** A revised endotoxin retesting procedure (SOP 210-8753-1)