FDA WARNING_LETTER - Tytan Medical, Corp. - October 28, 2010

On February 18, 2011, the FDA issued a Warning Letter to Tytan Medical, Corp. following an inspection from October 25-28, 2010, at their Shanghai, China facility. The inspection revealed that the firm's Class I stethoscopes and Class II manual sphygmomanometers are adulterated under section 501(h) of the Federal Food, Drug, and Cosmetic Act, as their manufacturing, packing, storage, or installation methods do not conform to the Quality System (QS) regulation (21 CFR Part 820).

Key violations include: 1. **Failure to establish and maintain design control procedures (21 CFR 820.30(a))**: No design control process was established for manual sphygmomanometers manufactured since 2004, and existing procedures from May 2006 were not implemented. Documentation for design plans, inputs, outputs, reviews, verification/validation, transfer, and history files was absent. 2. **Failure to adequately establish and maintain corrective and preventative action (CAPA) procedures (21 CFR 820.100(a))**: Procedure P-40008 did not specify manufacturing acceptance activity data for analysis. Data from critical sphygmomanometer gage accuracy tests (first and second (b)(4) point checks), defined by the A