Colgate warning letter
This article was originally published in The Tan Sheet
Executive Summary
Firm addressing GMP violations in production of Great Regular Flavor Colgate toothpaste identified in latest FDA warning letter. FDA Puerto Rico District's May 4 letter stems from March 29-April 6 inspection of firm's Guayama facility and comes less than two weeks after agency cited manufacturing problems for Colgate Sensitive Maximum Strength (1"The Tan Sheet" May 21, p. 16). Warning letter "relates to an in-process batch of toothpaste produced in 1999," Colgate notes, adding product was "totally safe and effective" when released to trade. Failure to reject adulterated batch, excessive active ingredient, inadequate controls for batch releases, failure to analyze each component for "purity, strength and quality" among violations identified by agency
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