Pink Sheet 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.

Menu

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
My View
Tags:

Guangdong BPC raw material receiving records, Kaiser repacking irregularities cited in warning letters.

  • News

Executive Summary

GUANGDONG PHARMACEUTICAL RECEIVING RECORDS ARE "INNACCURATE" and "incomplete" for the factory in Guangzhou City, China, FDA told the bulk pharmaceutical company in a March 10 FDA warning letter. The agency documented recordkeeping insufficiencies for raw material receiving records and finished product distribution records during an inspection of the Chinese BPC facility from Sept. 5 through Sept. 7.

Table

View full table

Tags:
Latest Headlines

Mismatch Between Growing Vaccine Pipeline and CDC’s ACIP Capacity

Keeping Track: Two Breakthrough Oncologics, Another Antibiotic Clear US FDA Along With Pfizer’s Hemophilia B Gene Therapy

Priority Review Vouchers: Tropical Disease Candidates Wait Years For FDA Action On Qualifying List

Pink Sheet Podcast: US FDA Biosimilar Strategy, Gene Therapy Accelerated Approvals, FDA v. Partisan Politics

See All
UsernamePublicRestriction

Register

PS025951

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

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