Alphatec Resolves FDA Warning Letter

Federal regulators have lifted a warning letter issued last summer against Alphatec Holdings Inc.’s spine division, the surgical instrument maker said.

The June 21, 2010 warning letter was issued after U.S. Food and Drug Administration (FDA) representatives inspected a factory the company operates at its headquarters in Carlsbad, Calif. The letter said inspectors found several violations at the facility, including:

• A failure to establish and maintain adequate procedures to perform design validation that ensures that devices conform to defined user needs and intended uses and include testing of production units under actual or simulated use conditions, as required by 21 CFR 820.30(g);
• A failure to implement procedures for implementing corrective and preventive actions, as required by 21 CFR 820.100(a);
• A failure to establish and maintain procedures for implementing corrective and preventive action, which shall include requirements for identifying the action(s) needed to correct and prevent recurrence of nonconforming product and other quality problems, as required by 21 CFR 820.100(a)(3);
• A failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit and to ensure that all complaints are processed in a uniform and timely manner, as required by 21 CFR 820.198(a)(1);
• A failure to establish and maintain adequate maintenance schedules for the adjustment, cleaning, and other maintenance of equipment to ensure that manufacturing specifications are met, as required by 21 CFR 820.70(g)(1); and
• A failure to submit MDR reports to FDA within 30 days of receiving or otherwise becoming aware of information that reasonably suggests a marketed device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur, as required by 21 CFR § 803.50(a)(2).

A re-inspection earlier by the FDA concluded that the company had fixed the violations. “The successful resolution of the warning letter demonstrates our commitment to maintaining a robust quality system throughout our organization,” Alphatec President and CEO Dirk Kuyper said in prepared remarks.

Alphatec Holdings in the holding company for Alphatec Spine, a manufacturer of products that treat disorders affecting the aging spine.