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Bad Drugs - Morton Grove Pharmaceutical accused of making bad drugs chooses to permanently close shop and layoff 66 workers

Bad Drugs - Morton Grove Pharmaceutical accused of making bad drugs chooses to permanently close shop and layoff 66 workers before Judge orders halt to manufacturing while they agreed on August 19, 2022 to a consent decree to stop making pharmaceuticals at its Illinois facility until it fixes the contamination issues ...

Morton Grove Pharmaceutical reported in the Illinois July 2022 Worker Adjustment & Retraining Notification that it planned to lay off a total of 66 employees by Oct. 31 due to closure.

https://www.illinoisworknet.com/LayoffRecovery/Pages/ArchivedWARNReports.aspx

Permanently restrain and enjoin, under 21 U.S.C. § 332(a), Defendants ... from manufacturing, processing, packing, labeling, holding, or distributing drugs from MGP, unless and until Defendants’ methods, facilities, and controls used to manufacture, process, pack, label, and hold drugs are established, operated, and administered in conformity with CGMP and the Act, in a manner that FDA finds acceptable.

SO ORDERED, this 19th day of August, 2022

Judge: Marvin E. Aspen Case No. 1:22-cv-04367

https://www.justice.gov/opa/press-release/file/1527456/download

District Court Enjoins Illinois Pharmaceutical Manufacturer from Making and Selling Adulterated Drugs

www.justice.gov

A federal court today ordered an Illinois company to stop manufacturing and distributing drugs alleged to be adulterated in violation of the Federal Food, Drug, and Cosmetic Act (FDCA).

In a civil complaint filed on Aug. 17, the United States alleged that Morton Grove Pharmaceuticals Inc., violated the FDCA at the company’s facility in Morton Grove, Illinois, by manufacturing and distributing adulterated drugs. Morton Grove Pharmaceuticals makes and distributes prescription and over-the-counter drugs, such as cough syrups and nasal sprays. The Department of Justice alleged that the company violated the FDCA by failing to have adequate procedures to prevent cross-contamination of equipment, failing to reject drug lots using a contaminated ingredient, and failing to fully investigate the root cause of such contamination. The department also alleged the Food and Drug Administration (FDA) inspected the company’s facility five times, in 2011, 2014, 2016, 2019, and 2021, and that many of the violations were repeat violations the FDA had identified in earlier inspections.

The current good manufacturing practice regulations mandate that manufacturers control the processes and procedures by which drugs are manufactured, processed, packed, and held, to ensure that drugs have the identity, strength, quality, purity, and other attributes necessary for their safe and effective use. Drugs not made in conformance with current good manufacturing practice regulations are adulterated and in violation of the law.

According to the Justice Department’s complaint, the FDA issued Morton Grove Pharmaceuticals several warnings, including a warning letter to the company in 2017, regarding alleged deficiencies at its facility.

“Drug manufacturers have an important responsibility to ensure drug quality and safety,” said Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Department’s Civil Division. “The Department of Justice will continue to work closely with the FDA and take action against manufacturers who fail to abide by laws designed to protect public health.”

“Pharmaceutical companies must manufacture and distribute prescription and over-the-counter drugs in compliance with federal law,” said U.S. Attorney John R. Lausch, Jr., for the Northern District of Illinois. “The U.S. Attorney’s Office is committed to working with our colleagues at the Department of Justice’s Consumer Protection Branch to ensure public health is not jeopardized.”

“Current good manufacturing practice requirements are the foundation of a safe and effective national drug supply,” said Director Donald Ashley of the FDA’s Center for Drug Evaluation and Research, Office of Compliance.

“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.”

The defendants agreed to settle the suit and be bound by a consent decree of permanent injunction. The negotiated consent decree entered by the court permanently enjoins the defendants from violating the FDCA, and requires, among other things, that the defendants stop manufacturing, processing, labeling, holding, or distributing adulterated drugs. Further, the defendants must destroy all drugs in the facility, except for those that are medically necessary.

Senior Litigation Counsels Donald Lorenzen and Christina Parascandola of the Civil Division’s Consumer Protection Branch prosecuted the case.

The U.S. Attorney’s Office for the Northern District of Illinois, along with Senior Counsel Michele Svonkin and Joshua A. Davenport of the FDA’s Office of Chief Counsel, provided valuable assistance.

Additional information about the Consumer Protection Branch and its enforcement efforts may be found at http://www.justice.gov/civil/consumer-protection-branch

The claims resolved by the resolution announced today are allegations only and there has been no determination of liability.

Consent Decree

https://www.justice.gov/opa/press-release/file/1527456/download

History of Noncompliance

MGP has a long history of violating the FDCA. Several of the CGMP deviations observed during the most recent inspection are similar to those that FDA investigators observed during prior inspections of MGP in August-October 2019, January- February 2016, January-March 2014, and December 2010-April 2011.

FDA’s inspections, and the repeat violations observed, demonstrate MGP’s unwillingness or inability to comply with the law. For example, FDA documented MGP’s failure to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications on at least four earlier occasions; MGP’s failure to establish adequate laboratory controls on at least two previous occasions; MGP’s failure to appropriately clean equipment and utensils on one prior occasion, in 2019, when FDA investigators observed residue, chipped paint, and rust on equipment, and considering that MGP uses the same equipment to manufacture different types of products but does not have processes to ensure against product cross-contamination; and MGP’s failure to establish and follow laboratory control mechanisms on one prior occasion.

FDA inspectors documented numerous other CGMP violations at MGP during at least two FDA inspections.

MGP’s noncompliance has continued despite repeated warnings from FDA. At the close of each of the five inspections of MGP that FDA conducted during the period starting December 6, 2010 and ending May 5, 2021, FDA investigators issued a detailed list of Inspectional Observations (“Form FDA-483”) to the most responsible person at MGP, in which the FDA investigators detailed the deficiencies that they observed during their inspections. In

each case, MGP responded to FDA either orally or in writing with promises to correct at least some of the CGMP violations.

Although MGP made some corrections in response to FDA’s inspectional observations, it either failed to correct others or failed to sustain the corrections it made, as shown by the FDA Investigators’ observations and documentation of ongoing, serious CGMP violations on each successive inspection of MGP’s facility.

18. FDA issued a warning letter to MGP in 2017, in which it described violations of the CGMP that FDA investigators observed during FDA’s inspection of MGP during the period starting January 4 and ending February 5, 2016. In the Warning Letter, FDA emphasized the serious nature of the violations and alerted MGP that further regulatory action may result if MGP

did not correct the deficiencies.

FDA held a regulatory meeting with MGP on November 20, 2014 to discuss the CGMP violations that FDA investigators observed during their January-March 2014 inspection of MGP. During this meeting, FDA stressed the importance of complying with all CGMP requirements and warned that if the violations were not corrected, FDA may pursue enforcement action.

Based on the foregoing, Plaintiff believes that Defendants will continue to violate the Act in the manner set forth above, unless the Court restrains them.

WHEREFORE, Plaintiff respectfully requests that the Court:

I. Permanently restrain and enjoin, under 21 U.S.C. § 332(a), Defendants MGP Venkatasan, and each of their officers, agents, representatives, employees, attorneys, and all persons in active concert or participation with any of them, from directly or indirectly doing any of the following acts:

a. Violating 21 U.S.C. § 331(a), by introducing or delivering, or causing to be introduced or delivered, into interstate commerce drugs that are adulterated within the meaning of 21 U.S.C. § 351(a)(2)(B); and

b. Violating 21 U.S.C. § 331(k), by causing drugs that Defendants hold for sale after shipment of one or more of their components in interstate commerce to become adulterated within the meaning of 21 U.S.C. § 351(a)(2)(B).

II. Permanently restrain and enjoin, under 21 U.S.C. § 332(a), Defendants, and each and all of their directors, officers, agents, representatives, employees, attorneys, successors, and assigns, and any and all persons in active concert or participation with any of them, from manufacturing, processing, packing, labeling, holding, or distributing drugs from MGP, unless and until Defendants’ methods, facilities, and controls used to manufacture, process, pack, label, and hold drugs are established, operated, and administered in conformity with CGMP and the Act, in a manner that FDA finds acceptable.

III. Authorize FDA to inspect Defendants’ places of business and all records relating to the receipt, manufacture, processing, packing, labeling, holding, and distribution of any drug or drug component, to ensure continuing compliance with the terms of the injunction, with the costs of such inspections to be borne by Defendants at the rates prevailing at the time the inspections are accomplished; and

IV. Award Plaintiff costs and other such relief as the court deems just and proper, including equitable monetary relief.

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Judge orders Morton Grove drug company to halt manufacturing

August 22, 2022 03:13 PM 7 HOURS AGO

Judge orders Morton Grove drug company to halt manufacturing

Morton Grove Pharmaceuticals has stopped production and plans 66 permanent layoffs while agreeing to a consent degree to stop making pharmaceuticals at its Illinois facility.

A federal district court on Aug. 19 ordered Morton Grove Pharmaceuticals to stop manufacturing and distributing drugs that were alleged to be adulterated, the U.S. Justice Department said in a statement.

The company is alleged to have violated the Federal Food, Drug & Cosmetic Act "by failing to have adequate procedures to prevent cross-contamination of equipment, failing to reject drug lots using a contaminated ingredient, and failing to fully investigate the root cause of such contamination," the Justice Department statement said.

The company had already decided to discontinue drug manufacturing and distribution at the facility at 6451 Main St. in Morton Grove before the negotiated consent decree was finalized, the decree stated.

The company reported in the Illinois July 2022 Worker Adjustment & Retraining Notification report that it planned to lay off a total of 66 employees by Oct. 31 due to closure.

The defendants agreed to settle the suit and be bound by a consent decree of permanent injunction, the Justice Department statement said. The negotiated consent decree also requires that the defendants must destroy all drugs in the facility, except for those that are medically necessary, the statement said.

Requests for comment from Morton Grove Pharmaceuticals, its parent company Wockhardt and its lawyers were not returned as of Crain's deadline.

The Justice Department’s complaint states that the U.S. Food & Drug Administration issued Morton Grove Pharmaceuticals several warnings, including a warning letter to the company in 2017, regarding alleged deficiencies at its facility.

In the 2017 FDA letter, Morton Grove Pharmaceuticals was accused of failing to thoroughly investigate when drug batches did not meet specifications, failing to ensure that laboratory records include complete data and failing to test in-process materials during production, among other violations.

“Drug manufacturers have an important responsibility to ensure drug quality and safety,” Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Department’s Civil Division, said in last week's statement. “The Department of Justice will continue to work closely with the FDA and take action against manufacturers who fail to abide by laws designed to protect public health.”

The consent decree said that defendants Morton Grove Pharmaceuticals and its current president, Gopalakrishnan Venkatesan, who assumed responsibility for overseeing manufacturing at the facility in July, did not admit or deny the allegations. If the company intends to resume, either directly or indirectly, manufacturing drugs at or from the facility, it must first notify the FDA, comply with the decree and be inspected by the FDA.

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Morton Grove Pharmaceuticals Sued Over Alleged FDCA Violations

byKendall Heebink

4 days ago

The United States of America filed suit on Wednesday in the Northern District of Illinois Eastern Division against defendants Morton Grove Pharmaceuticals, Inc. (MGP) and Gopalakrishnan Venkatesan. The complaint for permanent injunction alleges that the defendants’ drugs have been produced and marketed in violation of the Federal Food, Drug, and Cosmetic Act.

Defendant MGP “manufactures non-sterile prescription and over-the-counter finished drug products in the form of oral, topical, and nasal solutions, suspensions, and powders and distributes them to pharmaceutical wholesale distributors and large pharmacy chains.” Defendant Venkatesan is the president at MGP.

Drug manufacturers like MGP are required by the Federal Food, Drug, and Cosmetic Act (FDCA) to comply with the CGMP (current good manufacturing practice) for drugs. Specifically, the defendants must “control the processes and procedures by which the drugs are manufactured, processed, packed, and held in order to ensure that drugs have the identity, strength, quality, purity, and other attributes necessary for their safe and effective use.” If the defendants’ products are not made according to these guidelines, the products are considered adulterated under law.

Five separate FDA inspections determined that MGP’s drugs were adulterated since they were not in compliance with the CGMP. Some of the discrepancies uncovered by the FDA in their inspections included failures to reject and inspect drug lots that were potentially contaminated, failures to establish proper laboratory controls and sterilized environments, and more.

Defendant MGP represented in a June 2021 letter to the FDA that they were taking steps to correct their violations of the CGMP. However, the FDA ultimately concluded that “many of the firm’s proposed corrective actions [were] not adequate to fully address the CGMP violations that the FDA investigators observed during their inspection.” In their response, the FDA also referenced the defendants’ demonstrated history of noncompliance with the CGMP despite repeated warnings.

In the complaint, the plaintiff asserts their belief that the defendants will continue to violate the FDCA absent action from the Court. The plaintiff is seeking an injunction preventing further violations, preventing the sale of adulterated drugs, authorizing an FDA inspection of all business and records, and more.

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[ Sources for this report ]

District Court Enjoins Illinois Pharmaceutical Manufacturer from Making and Selling Adulterated Drugs Friday, August 19, 2022

https://www.justice.gov/opa/pr/district-court-enjoins-illinois-pharmaceutical-manufacturer-making-and-selling-adulterated

Morton Grove Pharmaceuticals Sued Over Alleged FDCA Violations

by Kendall Heebink August 18, 2022

https://lawstreetmedia.com/news/health/morton-grove-pharmaceuticals-sued-over-alleged-fdca-violations/

Judge orders Morton Grove drug company to halt manufacturing

August 22, 2022 03:13 PM

https://www.chicagobusiness.com/health-care/morton-grove-pharmaceuticals-ordered-stop-manufacturing



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