FDA WARNING_LETTER - Health Science Products Inc - August 10, 2011

During a July-August 2011 inspection, the FDA found Health Science Products, Incorporated, a manufacturer of dental chairs and operative units, in violation of the Federal Food, Drug, and Cosmetic Act. The devices are adulterated under 21 USC § 351(h) because manufacturing, packing, storage, or installation methods do not conform to Quality System (QS) regulation (21 CFR Part 820).

Violations include: - Failure to establish and maintain CAPA procedures (21 CFR 820.100(a)). - Failure to establish and maintain purchasing control procedures (21 CFR 820.50). - Failure to establish and maintain complaint procedures (21 CFR 820.198(a)). - Failure to establish and maintain process control procedures (21 CFR 820.70(a)). - Failure to adequately document acceptance activities (21 CFR 820.80(e)). - Failure to maintain adequate Device Master Records (DMRs) (21 CFR 820.181). - Failure to maintain adequate Device History Records (DHRs) (21 CFR 820.184). - Failure to establish and maintain document control procedures (21 CFR 820.40).

Additionally, devices are misbranded under 21