ProSun Tanning Industries, St. Petersburg, FL.

ProSun Tanning Industries, St. Petersburg, FL, Feb. 1 (Florida). The letter cited ProSun for failing to establish a quality policy and establish procedures for conducting quality audits. FDA cited the firm for the use of "handwritten assembly schematics" and for completion of Assembly History Records prior to completion of assembly. The firm also was cited for lack of complaint files and Medical Device Reporting procedures.

Investigator Ernest Clausenitzer inspected ProSun Dec. 28-29, 1999. C-H, MDR