Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

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
Advertisement

Related Content

Topics

Advertisement
UsernamePublicRestriction

Register

PS092613

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel