The Food and Drug Administration has filed a lawsuit accusing a Boca Raton pharmaceutical manufacturer of selling “adulterated” drugs and failure to correct violations cited by the FDA in 2018.
The suit accuses LGM Pharma LLC, headquartered at 6400 Congress Ave., Suite 1400, of failing to properly test imported ingredients to ensure safety and potency, failing to adequately evaluate suppliers of drug ingredients, and shipping products without disclosing that they had generated complaints from previous customers.
Dr. Prasad Raje, the company’s CEO, and Shailesh Vengurlekar, senior vice president for quality and regulatory affairs, are named in the suit as co-defendants.
LGM manufactures drugs in Colorado, Texas and California and sends them to a warehouse in Erlanger, Kentucky, for shipment to companies that sell them under various brand names.
The company imports “thousands” of active pharmaceutical ingredients from “hundreds” of suppliers, mostly from outside the United States, the FDA said in its lawsuit filed Jan. 11 in U.S. District Court in West Palm Beach.
FDA inspections of the Kentucky plant and LGM’s Boca Raton headquarters last March and April turned up “multiple instances” in which the company failed to follow “current good manufacturing practices” to ensure the drugs meet federal requirements for safety, strength, identity, quality and purity, the lawsuit states.
The parties are asking federal judge Aileen Cannon to approve a consent decree under which LGM would take actions to avoid future violations while not admitting or denying the FDA’s charges.
In a statement released Tuesday, LGM said it “vigorously disagrees” with the FDA’s allegations “and maintains that these allegations do not accurately portray the many quality measures that we have instituted.”
The statement continues, “Nevertheless, we have reached a resolution with the FDA that finalizes several long-resolved issues that originated under previous ownership and leadership of the supply chain division and which will enable the division’s continued operation.”
The FDA’s complaint stated that many of the violations noted in the March and April inspections were similar to violations observed in a 2018 inspection of the Kentucky facility.
According to the FDA’s complaint, violations noted in the 2022 inspections included:
•Failure to adequately investigate and resolve quality-related complaints. One customer reported out-of-specification test results concerning “unidentified impurities” in cromolyn sodium, a drug used to treat bronchial asthma and certain allergic conditions. LGM failed to quarantine remaining products from the same batch and shipped quantities to two additional customers.
•The company failed to follow its standard operating procedures when it learned of “multiple” test results relating to impurities and potential low potency of an estrogen hormone it purchased from a Chinese supplier and distributed to customers in the U.S.
•LGM failed to qualify and approve hundreds of ingredients purchased from multiple suppliers between late 2018 and early 2022.
•The company distributed multiple shipments of a product from a vendor that it disqualified without a written justification for the distribution.
•LGM failed to properly document investigations into deviations and complaints. The company’s documentation is “deficient in many respects.”
The FDA’s suit also accuses LGM of failing to address the identified violations in response to discussions that followed the 2022 inspections.
In its 2018 inspection report, the FDA noted that LGM received complaints about the potency consistency of a drug used to treat underactive thyroid conditions.
“Rather than quarantining the product pending an investigation into the cause for the [out-of-specification] testing results, Defendants accepted returns of the rejected product from customers, stripped any indication the drug had been previously distributed, and shipped it to other customers,” the complaint states.
The company also imported ingredients from suppliers on the FDA’s Import Alerts list, which gives the agency authority to detain imported drugs that appear to violate U.S. drug safety laws.
Despite the 2018 findings, LGM’s supplier qualification procedures and its lack of a quality control unit remained uncompliant four years later, the suit states.
Under terms of the consent agreement, LGM agreed to hire an expert to inspect its facilities and develop a comprehensive quality assurance and control program that includes development of standard operating procedures, prompt notification of violations, compliance training for LGM employees, and correction of any violations cited by “FDA, the expert or any other source.”
According to LGM’s statement on Tuesday, compliance with terms of the resolution is underway.
“We are now leading the industry by example by applying Quality by Design (QbD) principles throughout this division. This includes featuring an extensive global network of [drug ingredient] manufacturers that are FDA-registered and frequently audited to ensure quality and reliability.”
