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.
