Tanning Research responding to serious GMP violations after FDA warning letter.
This article was originally published in The Rose Sheet
Executive Summary
TANNING RESEARCH LABS RESPONDING TO 33 "SERIOUS" GMP VIOLATIONS involving sunscreen products cited by FDA during a routine inspection Jan. 28-Feb. 26 at the firm's manufacturing facility in Ormond Beach, Fla. Tanning Research Labs, which markets Hawaiian Tropic, Ski Pro and Ultra Sun Formula, said it is responding to FDA's findings of Good Manufacturing Practice violations with actions that have been, or are in the process of, addressing areas such as revamped documentation activities, increased staffing levels and the reconstruction of floors and walls. Tanning Research Labs said it considers a majority of the violations cited by FDA to be documentation issues.