HBW Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

US Still Rinsing Out OTC Sanitizer Warnings

Executive Summary

Of GMP warnings for OTC hand sanitizers, 114 have been submitted by FDA since pandemic began, with first sent in late April 2020, and another 12 for false COVID-19 claims, with first sent on 1 April. One GMP warning for hand sanitizer product is listed in both 2018 and 2019.

You may also be interested in...



House Republicans Criticize FDA Foreign Facility Inspections, Agency Publishes More Warnings

Oversight and Investigations Subcommittee conducts hearing as subcommittee chair Morgan Griffith and Energy and Commerce chair Cathy McMorris Rodgers leave no doubt they give FDA failing grade on foreign inspections. Five foreign facilities among firms in FDA’s latest warnings.

US FDA Warns NJ Firm On Drug And Supplement GMPs, Indian Firm On Diethylene Glycol Testing

Agency’s latest posting of warning letters submitted also includes more warnings about OTC hand sanitizer production failing to meet GMP requirements.

Plate Already Full Responding To Pandemic, US FDA Took On OTC Monograph Reform, ACNU Proposal

“The nonprescription drug space has been a bit challenging over the past two to three years as a result of the pandemic,” says CDER director Patrizia Cavazzoni.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

RS153475

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