Work'n Leisure Products, Inc. – FDA Warning Letter, Jan 25, 2012

On January 24-25, 2012, an FDA inspection of Leisure Products, Inc. in Kingsport, Tennessee, revealed significant violations regarding their sunlamp products, classified as devices. The devices were deemed adulterated under 21 USC 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820). The firm's January 31, 2012, response to the FDA 483 was inadequate.

Key violations include: 1. **Quality System Regulation (21 CFR Part 820):** * Failure to establish and maintain corrective and preventive action procedures (21 CFR 820.100(a)). * Failure to establish and maintain complaint procedures (21 CFR 820.198(a)), with no validation of complaint software. * Failure to establish and maintain acceptance activity procedures for in-process and finished device testing (21 CFR 820.80(a)). * Failure to establish and maintain purchasing control procedures and quality requirements for suppliers (21 CFR 820.50). * Failure to establish and maintain quality audit procedures and conduct internal audits (21 CFR 820.22). * Failure to identify product acceptance status throughout manufacturing (21 CFR 820