FDA WARNING_LETTER - I.T.S. GmbH - January 30, 2014

On January 27-30, 2014, an FDA inspection of I.T.S. GmbH in Lassnitzhoehe, Austria, revealed that the firm's non-sterile titanium implantable plates, screws, nails, and surgical instruments for trauma surgery were adulterated. The manufacturing, packing, storage, or installation methods did not conform to the Quality System (QS) regulation (21 CFR Part 820).

The firm's February 11, 2014, response to the FDA 483 was deemed inadequate. Violations included: 1. Failure to establish and maintain CAPA procedures, specifically lacking requirements for analyzing quality data to identify nonconforming product causes (21 CFR 820.100(a)(1)). The firm's response to revise SOP PD-7.6 lacked the revised procedure, implementation date, evidence of implementation, or training records. 2. Failure to establish and maintain procedures to control nonconforming product, including identification, evaluation, segregation, and disposition (21 CFR 820.90(a)). The firm's response to establish SOP (b)(4) lacked the revised procedure, implementation date, evidence of implementation, or training records. 3. Failure to establish and maintain procedures to evaluate complaints for Medical Device Reporting (MDR) requirements (21 CFR 820.19