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

FDA GMP Warning Letters Review: Foreign Drug Product Firms Hit Hard On GMP Basics

Executive Summary

Many of the 30 drug product firms that received FDA warning letters in 2016 were foreign cosmetics and hygiene manufacturers that appeared to need education on US GMP requirements. Another major focus in letters to drug product firms last year was sterility assurance in the US and abroad.

You may also be interested in...



Leaking Heat Cells In Pfizer's ThermaCare HeatWraps Prompt Recall

Firm's consumer health division extends to consumer level a recall it advised retailers and distributors about on Oct. 2 because products from the six lots have a potential to leak ingredients contained in heat cell wraps. A leaking heat cell in a HeatWrap could cause skin injuries such as burns, blisters or skin irritation on the applied areas.

Leaking Heat Cells In Pfizer's ThermaCare HeatWraps Prompt Recall

Firm's consumer health division extends to consumer level a recall it advised retailers and distributors about on Oct. 2 because products from the six lots have a potential to leak ingredients contained in heat cell wraps. A leaking heat cell in a HeatWrap could cause skin injuries such as burns, blisters or skin irritation on the applied areas.

Warning Letters Mount As FDA Completes Initial Inspections Of Under-The-Radar Facilities

Later this year, FDA expects to complete initial inspections of every facility that manufactures drugs for the US market. As the agency visits under-the-radar facilities recently targeted as part of an effort to leave no site uninspected, it is finding that they are more likely to have serious drug GMP issues.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS120473

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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