Pink Sheet is part of the Business Intelligence Division 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

Aveva's NRT adhesive problem a sticky GMP issue

This article was originally published in The Tan Sheet

Executive Summary

Adhesive failure and other problems associated with Aveva Drug Delivery Systems' OTC nicotine replacement therapy patches prompt an FDA warning letter on good manufacturing practices violations at the firm's manufacturing facility. In the May 21 letter, FDA said it found GMP violations in an Oct. 22-Dec. 4, 2009 inspection that cause Miramar, Fla.-based Aveva's OTC Nicotine TDDS products to be adulterated. The letter, posted on FDA's website June 8, said Aveva did not determine whether problems with the adhesive and sealant in the products affected the potency of the drug ingredients. Aveva recalled 27,456 14-count boxes of an OTC NRT patch in January 2010 after determining the product was out of specification for the myosmine and beta-nicotyrine degradant ingredients (1"The Tan Sheet" March 22, 2010, FDA Recalls). The firm "needs to explain the correlation between excessive potency failure and adhesive roll laminate properties," FDA said. Aveva received 570 complaints from August-October 2009 about NRT patch adhesive, according to the letter, which also says the firm did not follow written procedures for handling complaints
Advertisement

Related Content

Chart: FDA Recalls -- March 10, 2010

Topics

Advertisement
UsernamePublicRestriction

Register

PS104193

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