Category: Consent decree

Abbott Laboratories Infant Forumula

Here is the proposed consent decree, press release below, complaint and direct links to those documents. The proposed consent decree which Abbott Laboratories agreed to was filed by the United States Department of Justice. Upon Court approval, this will afford the opportunity for Abbott Laboratories to resume operations though under the parameters of the consent decree. The link to the letter from the United States Department of Justice regarding the safety of infant formula is included below and the final link is to the complaint.

https://www.justice.gov/asg/page/file/1506016/download

https://www.justice.gov/opa/pr/justice-department-files-complaint-and-proposed-consent-decree-ensure-safety-abbott

https://www.justice.gov/opa/press-release/file/1506076/download

Monday, May 16, 2022

Justice Department Files Complaint and Proposed Consent Decree to Ensure Safety of Abbott Laboratories’ Infant Formula

The United States has filed a complaint and a proposed consent decree that, if entered by a federal court in the Western District of Michigan, would allow Abbott Laboratories (Abbott) to resume manufacturing powdered infant formula at its Sturgis, Michigan, facility but also would require the company to take specific measures designed to increase safety and ensure compliance with the Federal Food, Drug, and Cosmetic Act (FDCA) and the U.S. Food and Drug Administration’s (FDA) Good Manufacturing Practice Requirements.   

“The actions we are announcing today will help to safely increase the supply of baby formula for families,” said Attorney General Merrick B. Garland. “The Justice Department will vigorously enforce the laws ensuring the safety of our food and other essential consumer products, and we will work alongside our partners across government to help make sure those products are available to the American people.”

In a complaint filed May 16, the United States alleged that Abbott, Division Vice-President of Quality Assurance Lori J. Randall, Sturgis Director of Quality Keenan S. Gale, and Sturgis Site Director TJ Hathaway manufactured powdered infant formula under conditions and using practices that failed to comply with regulations designed to ensure the quality and safety of infant formula, including protection against the risk of contamination from bacteria such as Cronobacter sakazakii. The Cronobacter sakazakii bacteria can live in dry foods, such as powdered infant formulas, and can cause deadly sepsis or meningitis in infants. The complaint further alleged that FDA testing of environmental samples taken in February detected Cronobacter sakazakii in the defendants’ manufacturing facility. 

Abbott has agreed to resolve the complaint in a proposed consent decree of permanent injunction. Under the proposed consent decree, which must still be reviewed and entered by a federal court, Abbott must retain outside expert assistance to bring its facility into compliance with the FDCA and good manufacturing practice regulations. Among other things, the expert will assist Abbott, under FDA supervision, in the development of plans designed to reduce and control the risk of bacterial contamination, and will periodically evaluate Abbott’s compliance with the FDCA, regulations, and the consent decree. The proposed consent decree also follows a thorough FDA inspection of the Sturgis facility and ongoing efforts by Abbott to address observations made during that inspection. The proposed consent decree sets out what Abbott must do to resume safely manufacturing infant formula at the Sturgis facility, which will help to mitigate the shortage of infant formula while also protecting public health.

“Federal laws regarding the safe manufacture of food, particularly food for infants, must be rigorously enforced,” said Principal Deputy Assistant Attorney General Brian Boynton, head of the Justice Department’s Civil Division. “The proposed consent decree underscores the Department’s commitment to protecting our most vulnerable citizens while also ensuring access to an essential product.”

“Parents who feed their babies formula must have confidence these products are safe,” said U.S. Attorney Mark Totten for the Western District of Michigan. “This proposed consent decree aims to protect one of our most vulnerable populations. My office is fully committed to supporting FDA and working with its partners at the Consumer Protection Branch to ensure manufacturers in our district comply with FDA’s safety regulations.”

“Today’s action means that Abbott Nutrition has agreed to address certain issues that the agency identified at their infant formula production facility in Michigan,” said FDA Commissioner Robert M. Califf, M.D. “The public should rest assured that the agency will do everything possible to continue ensuring that infant and other specialty formulas produced by the company meet the FDA’s safety and quality standards, which American consumers have come to expect and deserve. We recognize the hardships that parents and caregivers have faced in obtaining infant formula and the FDA is focused on boosting the availability of the country’s supply of these products, including new steps regarding importation. We are also taking a look at the supply of infant formulas developed by manufacturers across the country and around the world to determine if a reallocation of their distribution can be made to help get the right product to the right place, at the right time.”

Seizure and Consent Decree Unapproved Pharmaceuticals

Ascend Laboratories…Seizure and Consent Decree

The following is a recent FDA issued press release about Ascend Laboratories, LLC.  The court for the South District of Ohio entered the consent decree for permanent injunction against Ascend Laboratories, LLC. Besides the seizure action, the company is enjoined from manufacturing and distributing unapproved drugs until Ascend obtains approval from FDA. The action was based on inspections which revealed that the company was manufacturing approved drugs.

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm418867.htm

Federal judge approves FDA consent decree with Ascend Laboratories 

For Immediate Release: October 14, 2014 A federal judge from the U.S. District Court for the Southern District of Ohio entered a consent decree for permanent injunction against Ascend Laboratories, LLC, of Montvale, New Jersey on Oct. 10. The U.S. Department of Justice filed the consent decree on behalf of the U.S. Food and Drug Administration.

The consent decree requires Ascend Laboratories to post bond for the release of their unapproved drug products seized by U.S. Marshals in May 2014, which the company is then responsible for destroying under the FDA’s supervision. The drugs were seized at a warehouse in Cincinnati operated by Masters Pharmaceutical, Inc. (doing business as RXTPL).

In addition, the consent decree prohibits Ascend Laboratories and all other associated persons who act in concert with the company from manufacturing and distributing unapproved drugs until the company obtains FDA approval, including: Pramoxine-HC Otic Drops; Hydrocortisone Acetate Suppositories 25 milligrams; Urea Cream 39%; Urea Cream 40%; and Urea Lotion 40%.

“Manufacturing and distributing unapproved prescription drugs puts patients’ health at risk since they have not been found to be safe, effective or made using quality manufacturing practices,” said Ilisa Bernstein, acting director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “Companies that fall short of our requirements risk FDA action to stop the distribution of their products.”

The FDA inspected Ascend Laboratories’ New Jersey facility in November 2013 and Masters Pharmaceutical’s Cincinnati warehouse in February 2014. The inspections revealed that Ascend Laboratories was marketing drug products without FDA approval and adequate directions for use.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.