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


Consequences Escalate If Firms Ignore GMP Compliance Issues

This article was originally published in The Tan Sheet

Executive Summary

A warning letter is a firm’s last “real chance” to correct GMP violations without winding up in court, but not the only chance, says FDA attorney Annamarie Kempic. She outlines factors the agency weighs when considering enforcement actions.


Related Content

J&J Prioritizes OTC Return With McNeil Remediation End In Sight


Related Companies




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