FDA WARNING_LETTER - Kayline Inc. - June 03, 2008

On May 19-23 and June 3, 2008, an FDA inspection of Kayline, Inc. in Cleveland, Tennessee, revealed that the firm's automated lift chairs, classified as medical devices, were adulterated. This was due to non-conformity with Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820). The firm failed to respond to the issued Form FDA 483.

Violations included: 1. Failure to maintain Device Master Records (DMRs) as required by 21 CFR 820.181. 2. Failure to establish and maintain procedures for purchased products and services, including vendor audits and written agreements with suppliers (21 CFR 820.50). 3. Failure to establish and maintain written procedures for acceptance of incoming components and to perform inspections (21 CFR 820.80(a) and (b)). 4. Failure to establish and maintain Corrective and Preventive Action (CAPA) procedures, investigate non-conforming products (e.g., transformers, hand controls, lift frames), and document CAPA activities (21 CFR 820.100(a)(1) and (2); and (b)). 5. Failure to follow procedures for controlling non-conforming products and documenting their