FDA WARNING_LETTER - The Standing Company - May 20, 2010

On August 20, 2010, the FDA issued a Warning Letter to The Standing Company, following an inspection from May 5-20, 2010. The inspection revealed that the firm's Superstand and Powerstand Stand-up Wheelchairs 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).

Violations include: 1. Failure to establish and maintain a design history file for each device type (21 CFR 820.30(j)), specifically lacking design and development plans, inputs/outputs, reviews, verification, and validation for the Powerstand Stand-up Wheelchair (models HPS-2 and PS-2). 2. Failure to establish and maintain procedures for design change control (21 CFR 820.30(i)), evidenced by the unproceduralized addition of a reclining back to Superstand (SS-1) and Powerstand (HPS-2, PS-2) models around February 2009. 3. Failure to establish and maintain adequate corrective and preventive action (CAPA) procedures, including analysis of quality data using statistical methodology (21 CFR