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 Warning Letters Hit Three Repackers For Failing To Identify Original API Makers

Executive Summary

The US FDA’s concerns about the transparency of the pharmaceutical supply chain surfaced in three recent drug GMP warning letters to drug repackers of active pharmaceutical ingredients who failed to disclose the names of the API manufacturers to their customers. Janet Woodcock, director of the agency's drug center, called such lack of transparency a "real threat" to public health that must be addressed quickly.

You may also be interested in...



Data Integrity Remains Challenging For API Manufacturers

Data integrity issues were raised in many warning letters to active pharmaceutical ingredient manufacturers over the past four years.

US FDA Says Data Integrity Remains Challenging For API Manufacturers

Data integrity issues were raised in many warning letters to active pharmaceutical ingredient manufacturers over the past four years.

First-Time OTC Facility Inspections Drove US FDA Warning Letter Surge In FY 2019

The good news: 75% of firms not previously inspected were in compliance with US drug GMP requirements; the bad news, 25% weren't. CDER Office of Manufacturing Quality director Francis Godwin says FDA remains concerned about vulnerabilities in supply chain when OTC firms don't test products for impurities that have harmed and killed consumers in the past.

Related Content

Topics

UsernamePublicRestriction

Register

PS125582

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