HBW Insight 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

UsernamePublicRestriction
UsernamePublicRestriction

Warnings Up As FDA Trims Its List Of Uninspected OTC Drug Manufacturers

Executive Summary

Hundreds of foreign OTC drug firms marketing products in US had not been inspected for GMP compliance before FDA Safety and Innovation Act of 2012 pointed agency toward crossing those facilities off its list. Of the foreign OTC facilities inspected between June 2016 and January 2018, 25% received "official action indicated" inspection results, prompting warning letters and import alerts.

Advertisement

Related Content

FDA Warnings: Mariposa Done With OTCs, Thibiant's Long Correction List
US FDA Crossing Off More Foreign OTC Firms On Globalization Checklist
FDASIA Study Mandates Focus On Performance, But Could Slow Reviews

Topics

Advertisement
UsernamePublicRestriction

Register

RS139923

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