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

FDA Global Supply Chain Concerns Prompt Glycerin DEG Testing Guidance

This article was originally published in The Tan Sheet

Executive Summary

Pharmaceutical manufacturing facilities and compounding pharmacists should include tests for diethylene glycol content in the identity testing of all lots of glycerin they receive, according to an FDA guidance reflecting growing concern about vulnerabilities in the global supply chain

You may also be interested in...



The Quality Lowdown: Yes, The US FDA Expects You To Heed Import Alerts And Testing Requirements

PCCA repackaged adulterated APIs, Allay failed to understand processes, ShangRao and Mexican firms peddled subpotent, sometimes methanol-tainted ethanol.

US FDA Calls For Drugmakers To Test Alcohol Ingredients For Methanol

The US FDA wants manufacturers and compounding facilities to test drug products for methanol in alcohol ingredients, and responds to reports of fatal methanol poisonings of consumers who ingested alcohol-based based hand sanitizers.

More GMP Warnings, Import Alerts For OTC Firms As US FDA Capped List Of Uninspected Facilities

Most of the foreign OTC drug firms targeted in latest warnings FDA published, including the GUM oral care brand manufacturer, were placed on import alert due to GMP violations. Each was inspected by FDA during June, July or May 2019, when the agency was wrapping up an initiative to inspect all previously uninspected drug manufacturers.

Related Content

Topics

UsernamePublicRestriction

Register

LL009864

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