HBW Insight 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

Records From Down Under Put Personal Care Product Provider Under US Regulatory Thumb

Executive Summary

FDA’s remote assessment using documents Natural Beauty Care Pty provided led to a warning and an import alert. Melbourne area contract manufacturer responded to FDA request in April 2020, soon after agency stopped international inspections due to the coronavirus pandemic.

You may also be interested in...



Remote Site Visits Will Help US FDA Keep Reviews On Track As Pandemic Constraints Continue

Guidance discusses what are generically called virtual inspections, but which the agency terms “remote interactive evaluations.” As site inspections remain constrained by the pandemic, remote interactive evaluations “should help FDA operate within normal timeframes,” the document says.

US FDA Resumes China, India Inspections In Bid To Keep Drug Approvals On Schedule

Agency’s struggle to meet user fee commitments despite travel restrictions expected to worsen as pandemic continues into 2021.

Spike In Drug Recalls Expected As US FDA Resumes Inspections, Targeting COVID-19-Related Problems

Attorneys and recall consultants say any firm distributing products associated with COVID-19 should expect to receive the highest level of scrutiny as the US FDA resumes inspections and uses its enforcement muscle to prohibit companies from making adulterated products, such as hand sanitizers, or making fraudulent claims.

Related Content

Topics

UsernamePublicRestriction

Register

RS151690

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