Cybernet Systems Corp. – FDA Warning Letter, Oct 30, 2009

On January 15, 2010, the FDA issued a Warning Letter to Cybernet Systems Corporation following an inspection from September 9, 2009, to October 30, 2009. The inspection revealed that the firm's MedStar System products (CHF, COPD, and Diabetes MedStar Sets) 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 Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820).

Key violations include: 1. Failure of management with executive responsibility to fully implement and maintain an adequate quality system (21 CFR 820.20). The firm has not designated a management representative (21 CFR 820.20(b)(3)) or established management review procedures (21 CFR 820.20(c)), with no reviews conducted since 2004. 2. Failure to conduct quality audits since 2004 (21 CFR 820.22). 3. Design validation failed to include testing of production units under actual or simulated use conditions (21 CFR 820.30(g)), specifically lacking documentation for physiological data transmission accuracy. 4.