FDA WARNING_LETTER - Graftys, S.A. - March 07, 2013

On March 4-7, 2013, an FDA inspection of Graftys, S.A. in Aix En Provence, France, identified violations regarding their Class II Bone Void Fillers (BCP and HBS Bone Void Filler devices). The devices were deemed misbranded under section 502(t)(2) of the Act due to failure to furnish required information under section 519 and 21 CFR Part 803 (Medical Device Reporting - MDR).

Key violations included: 1. **Inadequate MDR Procedures (21 CFR 803.17(a)):** The firm's "EXIGENCES REGLEMENTAIRES USA APPLICABLES" procedure lacked internal systems for standardized review to determine reportability, instructions for event investigation and timely evaluation, and guidance for timely transmission of complete MDRs (e.g., obtaining/completing FDA 3500A, submitting all known information, correct submission address). The firm's May 27, 2013, response was inadequate, and the procedure still referenced outdated baseline reports and annual certifications. 2. **Quality System Deficiencies (21 CFR Part 820):** * **Complaint Handling (21 CFR 820.198(a)):** Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints. The complaint form did not require evaluation for