FDA WARNING_LETTER - Torbot Group Inc., Jobskin Division - February 14, 2008

On January 28 through February 14, 2008, an FDA inspection of Torbot Group Inc., Jobskin Division, in Toledo, OH, revealed that the firm's compression garments for burn victims and lymphedema are adulterated. The manufacturing, packing, storage, or installation methods and controls do not conform with the Quality System (QS) regulation (21 CFR Part 820).

Violations include: 1. Failure to implement corrective and preventive procedures to analyze quality data sources (internal failures, supplier issues, complaints) to identify nonconforming product causes and trends (e.g., 467 reworks, 36 wrong product shipments, 7 out of 20 main component failures not investigated). [21 CFR § 820.100(a)] 2. Failure to document corrective and preventive action activities, such as investigations into fabric failures and evaluation of new suppliers, relying only on emails and test results. [21 CFR § 820.100(b)] 3. Failure to establish procedures for finished device acceptance, specifically not verifying patient measurements for custom garments. [21 CFR § 820.80(d)] 4. Failure to establish quality requirements for suppliers, particularly for the main component, and not performing supplier evaluations since 2003 despite fabric test failures. [21 CFR §