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Colgate Sensitive Maximum Strength Considered "New Drug" By FDA

This article was originally published in The Tan Sheet

Executive Summary

Colgate-Palmolive plans to meet with FDA to discuss the status of its Colgate Sensitive Maximum Strength toothpaste, which has been cited for content and labeling violations in an agency warning letter.

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Colgate warning letter

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

Colgate warning letter

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

Colgate warning letter

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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