American· Optisurgical Inc. – FDA Warning Letter, Feb 23, 2012

On June 14, 2012, the FDA issued a Warning Letter to American Optisurgical Inc. following an inspection from January 30, 2012, to February 23, 2012. The inspection revealed that the firm's TX1 Tissue Removal System, classified as a device under section 201(h) of the Federal Food, Drug, and Cosmetic Act, was adulterated. The manufacturing, packing, storage, or installation methods and controls did not conform to the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820).

The letter detailed nine violations, with the firm's responses dated March 7, 2012, and May 29, 2012, deemed inadequate. Key violations included: 1. Failure to validate design under actual or simulated use conditions (21 CFR 820.30(g)). 2. Failure to adequately document design inputs (21 CFR 820.30(c)). 3. Failure to adequately document design outputs (21 CFR 820.30(d)). 4. Failure to document process validation activities (21 CFR 820.75(a)). 5. Failure to validate production software for its intended use (21 CFR 8