Hair Labs International, Inc. – FDA Warning Letter, Apr 19, 2013

On April 19, 2013, FDA investigators inspected Hair Labs International, Inc., a specification developer/manufacturer of the Class II/IIIa medical laser device, AlphaLase LX50. The inspection revealed the device is adulterated under Section 501(h) of the Act due to non-conformity with Quality System (QS) regulation (21 CFR Part 820). The firm failed to establish and maintain critical QS procedures, including those for complaint handling (21 CFR 820.198(a)), quality audits (21 CFR 820.22), purchasing controls (21 CFR 820.50), and corrective and preventive actions (CAPA) (21 CFR 820.100(a)). Significant deficiencies were also noted in design controls (21 CFR 820.30(a)(1)), Design History Files (DHF) (21 CFR 820.30(j)), Device Master Records (DMR) (21 CFR 820.181), and Device History Records (DHR) (21 CFR 820.184). Management also failed to review the quality system (21 CFR 820.20(c)) and establish quality policy (21 CFR 820.20(a)). Furthermore, the device is misbranded under Section 502(t)(2) due to the firm's failure to develop and implement written Medical Device Reporting (MDR) procedures (21 CFR 803.17). The AlphaLase LX50 is also adulterated under Section 501(f)(1)(B) because the firm lacks an approved Premarket Approval (PMA) or Investigational Device Exemption (IDE) application, and misbranded under Section 502(o) for failing to submit a 510(k) premarket notification. Hair Labs International, Inc. must promptly correct all violations and respond within fifteen working days with a comprehensive plan, including a timetable and documentation. Failure to comply may result in regulatory actions such as seizure, injunction, civil money penalties, and impact on federal contracts and future device approvals.