FDA WARNING_LETTER - Alphatec Spine, Inc. - March 13, 2015

An FDA inspection of Alphatec Spine, Inc. from February 4 to March 13, 2015, revealed that their sterile pedicle screw implants and stainless steel instruments are adulterated under 21 U.S.C. § 321(h) due to non-conformity with Quality System regulation (21 CFR Part 820).

Key violations include: 1. **Failure to validate design under actual/simulated use (21 CFR 820.30(g)):** The Illico MIS Screw Extension (SE) System's (b)(4) design was not validated, despite 28 MDR-reportable complaints. 2. **Failure to establish a design history file (21 CFR 820.30(j)):** No DHF exists for the (b)(4) spinal implant device acquired around (b)(4) prior to that date, hindering failure investigations and recalls. 3. **Failure to maintain a device history record (21 CFR 820.184):** Incomplete DHRs for the acquired (b)(4) device, impacting failure investigations and recall efforts. 4. **Failure to adequately document corrective and preventive actions (21 CFR 820.100(b)):** No records of a previous recall for the (b)(4) device, including disposition