In a consent decree entered in US District Court for the Eastern District of New York, a permanent injunction was filed against a company called Riddhi USA based in Ronkonkoma, NY and its owner Mohd M. Alam. The company, which is not currently manufacturing any dietary supplements, cannot resume unless and until they hire an expert to ensure that they are following GMP regulations and pass an FDA inspection.
“Dietary supplement companies put the public’s health at risk when they repeatedly fail to follow good manufacturing practice regulations and omit require information about the product in their labeling,” said Melinda Plaisier, FDA’s associate commissioner for regulatory affairs. “The FDA will continue to take action to protect the American public when companies violate the law.”
Riddhi is a whole sale manufacturer of supplements, according to FDA. As is often the case, the action taken against the company came at the end of a long road.
Long road to injunction
In late April of 2016 the company received a warning letter from FDA detailing serious GMP violations. According to the letter, the company had failed to establish specifications for a number of products including a men’s health product and a prenatal product. And, without specifications, there was no finished product testing to verify that the specs had been met.
In addition, the company showed a complete lack of identity testing on incoming ingredients. The company also had no written procedures quality control procedures, and had gaps in its master manufacturing records. The batch manufacturing records also were deficient, as were cleaning and maintenance logs for equipment. The company also had no procedure for receiving complaints.
The injunction which was made final yesterday was first filed in preliminary form in November of last year. One of the things mentioned in that action was that the company was not properly calling out a potential allergen—soy. Getting this aspect of labeling correct will assume even greater urgency under new FSMA regulations, said expert Larisa Pavlick, vice president of regulatory and compliance for the United Natural Products Alliance. There were also numerous labeling violations, including problems with how ingredients were called out on labels, lack of an address for the manufacturer, etc.
Alam, owner of the company, was reached by phone. He said the facility in question is small—only about 5,000 square feet. He declined further comment until he was able to meet with his lawyers later on Friday.