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

FDA Says Shandong Vianor Biotech Falsified Data And Impeded Inspection

Executive Summary

FDA warning letter says Shandong Vianor Biotech in China falsified test results and barred an investigator from entering a laboratory during an inspection of the firm’s facility in May.

You may also be interested in...



US FDA Guidance On Interference With Inspections Needs More Detail, Attorneys Say

Agency should clarify how quickly it expects requested documents to be produced before a company is determined to have delayed an inspection, attorneys say during a FDLI meeting discussion of how a 2012 law enabling the agency to put a foreign facility on import alert for delaying, limiting, or refusing an inspection has played out.

Manufacturing Compliance Updates, In Brief

FDA warning letter says Foshan Flying Medical Products needs to hire more people in quality control and improve its sterility testing; EU GMP noncompliance notice goes to Bristol Labs in the UK for data integrity flaws; FDA hits six firms with drug GMP import alerts.

Program Participants Urge The FDA To Adopt Some Pharmaceutical Quality Metrics And Avoid Others

Site-based metrics praised; lot acceptance rates, invalidated OOS rates discouraged. Agency official admits some proposed metrics were “not the best.”

Topics

UsernamePublicRestriction

Register

PS121654

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