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 Warning Letters Hit Small OTC, Large Pharma Firms With Same Citations In FY 2019

Executive Summary

Inadequate process controls and faulty failure investigations were the top GMP violations found in warning letters sent in FY 2019 to companies large and small.

You may also be interested in...



First-Ever OTC Inspections Drove Surge Of FDA Warning Letters In FY 2019

The good news: 75% of never-before-inspected firms complied with US drug GMP requirements. The bad news: 25% did not.

Mylan's Manufacturing Maelstrom: Trans-Atlantic Recalls And Personal Citation By Gottlieb

GMP quality, once Mylan's calling card, is now an ongoing problem, forcing product discontinuations and apologies to customers. Firm's valsartan products have European certificate of suitability suspended as Morgantown, W.Va. facility draws US FDA warning letter.

FDA Officials Cite Reasons For Denying Application Reviews Over Data Integrity Breaches

Officials from the US Food and Drug Administration cited their reasons for refusing to review new applications for companies with unresolved data integrity failures.

Topics

Related Companies

UsernamePublicRestriction

Register

PS142970

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