FDA WARNING_LETTER - Sandstone Medical Technologiess, LLC - April 18, 2008

On April 8, 10, and 18, 2008, an FDA inspection of Sandstone Medical Technologies, LLC, an initial importer, manufacturer, and relabeler of Class II Medical Laser Systems, revealed significant violations of Current Good Manufacturing Practice (CGMP) and Quality System (QS) regulations (21 CFR 820). The firm's devices were deemed adulterated under Section 501(h) of the Act.

Key violations included: 1. **Failure to establish and maintain an adequate quality system (21 CFR 820.20):** No documented quality policy or procedures for manufacturing, distribution, device master/history records, acceptance activities, quality audits, training, design control, document control, purchasing, change control, process controls, labeling, marketing/distribution, non-conforming product control, or complaint handling. 2. **Failure to establish CAPA procedures (21 CFR 820.100(a)):** No written corrective and preventive action procedures. 3. **Failure to establish and maintain complaint files and procedures (21 CFR 820.198(a)):** No formal unit or procedures for complaint handling, and failure to evaluate complaints for Medical Device Reporting (MDR) requirements (21 CFR 803). Ten service reports appeared to be complaints, with one potentially requiring MDR. 4.