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.

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

Guardian Pharmacy Ordered To Stop Making Sterile Drugs Under Terms Of Consent Decree

Executive Summary

Drug compounding pharmacy Guardian Pharmacy Services was ordered to stop manufacturing sterile drugs after ignoring quality problems for too long, bringing to two the number of decrees the Justice Department has filed against drug compounding pharmacies so far this year, which at the current rate may exceed the two consent decrees filed in all of calendar year 2018. The action follows reports that patients administered eye injections of a drug compounded by Guardian during cataract surgery developed vision impairment.

You may also be interested in...



The Quality Lowdown: Diversion, Cross-Contamination And PR Mix-Ups

McKesson meets with US FDA over opioid diversion warning letter, while UK MHRA takes risk-based approach to cross-contamination recalls and firm says it’s the other Guardian Pharmacy.

The Quality Lowdown: ICH Q13 and Q14, Gene Therapy CMC, Drug Shortage Gaps, And An Excipient Misstep

ICH launches continuous manufacturing and analytical procedure guidelines while US FDA promises advice on gene therapy CMC, battles drug shortages and sees what went wrong with certain eye injections.

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

Latest Headlines
See All
UsernamePublicRestriction

Register

PS124933

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