FDA WARNING_LETTER - Bacterin International, Inc. - July 27, 2012

On July 19-27, 2012, an FDA inspection of Bacterin International, Inc. in Belgrade, Montana, revealed that their Elutia and Via Wound Drains were adulterated and misbranded. The devices were adulterated under Section 501(h) of the Act, 21 U.S.C. § 351(h), due to non-conformity with Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820).

Key violations include: 1. **Failure to establish and maintain procedures for purchased product and services (21 CFR 820.50):** Supplier performance reviews and audits were not conducted as per procedure, exemplified by a significant delay in auditing a supplier despite noted quality issues. The firm's planned updates to the Supplier Qualification system and procedure, and associated retraining, were not provided to the FDA by the stated deadline. 2. **Failure to control nonconforming product (21 CFR 820.90(a)):** A "Use As Is" disposition for a nonconforming lot of Elutia 19 Fr Wound Drain lacked required scientific justification. The firm's planned retraining on Nonconformance Reports and justification, and a letter to file for the specific case, were not documented as completed. 3. **Failure to establish and maintain procedures