Morton Grove Pharmaceuticals to discontinue operations at Illinois site due to ongoing manufacturing issues

23 Aug 2022
endpts.com
Generic DrugVaccineCollaborate
An Indian manufacturer is shuttering its Illinois site due to manufacturing issues that have built up over several years. Morton Grove Pharmaceuticals, a generics manufacturer and subsidiary of Mumbai-based drug company Wockhardt, has agreed to discontinue all manufacturing, processing and drug distribution from its Illinois site after the Department of Justice accused it of selling adulterated drugs. The DOJ brought a suit against Morton Grove and Gopalakrishnan Venkatesan, VP of business development at Wockhardt, earlier this month that alleged the company’s syrups and nasal sprays made at the facility were not made in compliance with cGMP standards. Five FDA inspections between 2010 and 2021 at Morton Grove’s facility found that facilities and controls used for manufacturing, processing and holding were not in compliance with cGMP practices. This included a lack of controls and improper cleaning or sterilization of utensils, among other quality control failures. The suit also alleges that the facility has a history of noncompliance, with the facility having been docked for similar violations over the course of several FDA inspections. A federal court on Friday enjoined the company from manufacturing adulterated drugs, and ordered the company to destroy all drugs in its facility except those that are medically necessary. Morton Grove has entered a consent decree, in which it agreed to discontinue its operations, close the business and sell the Illinois site. Morton Grove may continue holding its noncommercial samples of drug products; however, these products cannot be commercially distributed. “Current good manufacturing practice requirements are the foundation of a safe and effective national drug supply. These manufacturing fundamentals are necessary to ensure the public is not put at risk from adulterated drug products. Today is a culmination of the dogged oversight needed to hold drug manufacturers accountable for the safety, efficacy and quality of the drug products they produce as we work to best protect public health,” said Donald Ashley, director of the FDA’s Center for Drug Evaluation and Research’s Office of Compliance, in a statement . Wockhardt, which produces a wide range of generic drugs, is certainly no stranger to the FDA, with a site in India having come under scrutiny in the past . Other Indian manufacturers have been under the FDA’s microscope this year, with Sun Pharma being the latest to get the 483 hit. The scrutiny, however, has not stopped Wockhardt’s expansion , as earlier this year it announced a partnership with Serum Life Sciences UK, a subsidiary of the Serum Institute of India, to help deliver a global vaccine program, with the companies building a new sterile fill-finish facility in North Wales.
For more details,please visit the original website
The content of the article does not represent any opinions of Synapse and its affiliated companies. If there is any copyright infringement or error, please contact us, and we will deal with it within 24 hours.
Organizations
Indications
-
Targets
-
Drugs
-
Chat with Hiro
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.