FDA WARNING_LETTER - Globus Medical, Inc. - June 04, 2013

An FDA inspection of Globus Medical Inc. from May 7 to June 4, 2013, revealed that their Microfuse Putty device is adulterated under 21 U.S.C. § 351(h) due to Quality System regulation violations (21 CFR Part 820) and misbranded under 21 U.S.C. § 352(t)(2) due to Medical Device Reporting (MDR) violations (21 CFR Part 803). Quality System deficiencies included failure to document review and evaluation of process changes/deviations (21 CFR 820.75(c)), specifically regarding a sterility dose audit failure and lack of re-validation. The firm also failed to control nonconforming products (21 CFR 820.90(a)), releasing lots of MicroFuse Putty that did not meet mechanical specifications based on unvalidated qualitative assessments. Additionally, there was a failure to establish environmental control procedures (21 CFR 820.70(c)), with unmonitored and inoperable cleanroom pressure gauges. MDR violations included significant delays in reporting serious injuries (21 CFR 803.50(a)(1)) and device malfunctions (21 CFR 803.50(a)(2)), with one report delayed over 2.5 years. The firm also failed to adequately develop and implement written MDR procedures (21 CFR 803.17), lacking definitions for reportable events and instructions for timely reporting. The firm's June 24, 2013, response was deemed inadequate for all violations. Globus Medical Inc. must take prompt corrective actions within fifteen business days to address these systemic issues, or face potential regulatory actions including seizure, injunction, civil money penalties, and impact on federal contracts and device approvals.