FDA WARNING_LETTER - SystemsOne, LLC - November 16, 2011

On March 6, 2012, the FDA issued a Warning Letter to SystemsOne, LLC, following an inspection from November 14-16, 2011, at their Stuart, Florida facility. The inspection determined that the firm manufactures the Electrophysiology Systems Integrator (EPSI), classified as a device under section 201(h) of the Federal Food, Drug, and Cosmetic Act.

The devices were found to be adulterated under section 501(h) of the Act, as manufacturing, packing, storage, or installation methods and controls did not conform to the Quality System (QS) regulation (21 CFR Part 820). The firm's response to the FDA 483, dated December 30, 2011, was not reviewed due to late submission.

Key violations include: 1. Failure to establish and maintain adequate procedures for device design validation (21 CFR 820.30(g)), including software validation and testing documentation. 2. Failure to establish and maintain adequate procedures to control device design (21 CFR 820.30(a)), including lack of design control and risk analysis procedures. 3. Failure to establish and maintain adequate procedures for corrective and preventive actions (21 CFR 820.100(a)) and to document them (21 CFR 82