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The CEO of a Davie drug firm helped trigger infections in kids in two hospitals by distributing a drug he knew most likely had a bacterial contamination. And 42-year-old Raidel Figueroa hid from the FDA that his firm made the drug in query, Diocto Liquid.
Figueroa, a Miami-Dade father of three and the proprietor of two suburban properties, was sentenced final week to 3 years in federal jail for his actions. His give up date is Nov. 30.
Figueroa’s full sentence is 37 months after he pleaded responsible to conspiracy to defraud the United States; destruction, alteration, falsification of information in a federal investigation; obstruction of departments or businesses; and adulteration or misbranding of meals and medicines.
Figueroa’s firm, PharmaTech, doesn’t exist, but its website remains. Click on on “Highest Requirements of Integrity,” and the phrases beneath “Our Company Values” declare: “As a company, we are going to proceed to function with the very best requirements of integrity and compliance in order that our clients and customers profit in acquiring safer high quality merchandise.”
Diocto Liquid and B. cepacia
Based on Figueroa’s responsible plea, he informed the FDA that he “had the obligation, accountability and authority for making certain that PharmaTech’s merchandise complied with all related legal guidelines, together with the Federal Meals, Drug and Beauty Act” and “he had the accountability for stopping, detecting and correcting any violations of these legal guidelines at PharmaTech.”
So it fell on Figueroa’s plate when the FDA confirmed up at PharmaTech on July 5, 2016. An outbreak of Burkholderia cepacia (B. cepacia) infections may hint to PharmaTech’s Diocto Liquid, a drug used to deal with constipation. Each the FDA and PharmaTech had received complaints about the product.
Due to the attainable contamination, on July 15, 2016, PharmaTech voluntarily recalled all plenty of Diocto made for The Harvard Drug Group, which distributed it by Rugby Laboratories. After the recall, the FDA gave Figueroa a listing of “objectionable circumstances at PharmaTech” observed by inspectors.
A type of circumstances was that a water pattern from PharmaTech’s water system examined constructive for B. cepacia. On Jan. 17, 2017, the FDA met with Figueroa.
“Throughout the assembly, [Figueroa] suggested the FDA that PharmaTech had addressed PharmaTech’s water points and that a 100% new water system was put in,” Figueroa’s responsible plea acknowledged. “The FDA suggested [Figueroa] that the FDA nonetheless had considerations concerning the distribution of medicine previous to an FDA inspection and requested [Figueroa] to voluntarily inform the FDA when PharmaTech began distributing merchandise, which he agreed to do.” He didn’t.
Laxative secrets and techniques
On March 7, 2017, PharmaTech shipped lot No. 20351701 of Diocto Liquid, 7,308 models to The Harvard Drug Group with out telling the FDA. When FDA inspectors got here again to PharmaTech’s facility at 4131 SW forty seventh Ave. on March 20, 2017, they requested Figueroa for a listing of all of the merchandise the corporate made after it resumed manufacturing in November 2016.
Figueroa gave them a listing that deliberately didn’t embody Diocto Liquid. It took FDA investigators every week to ask for a second listing as a result of they knew the primary listing was “incomplete.” Figueroa handed over one other listing, nonetheless absent Diocto Liquid, which he “falsely represented to the FDA as a whole listing of all of the merchandise” PharmaTech made after November 2016.
The next week, Figueroa signed a memo to the FDA that acknowledged all the information for the Section 3 testing of PharmaTEch’s water system had “met acceptance standards.”
Figueroa’s responsible plea admission of info says he knew that a water system pattern taken on Feb. 15, 2017, had “examined presumptive constructive for the presence of B. cepacia.”
Sick children coast-to-coast hint again to Davie
B. cepacia infections “pose little medical risk to healthy people,” the CDC says. However individuals with broken immune programs or lung ailments will be extra susceptible to critical respiratory infections and different infections that may be deadly. As Figueroa’s responsible plea states, “the micro organism had been typically immune to widespread antibiotics.”
July 2017 introduced CDC investigations of B. cepacia infections at Johns Hopkins Kids’s Heart in Baltimore and Stanford Kids’s Well being Lucile Packard Kids’s Hospital in Palo Alto, California.
Working with the CDC, the FDA scooped up three unopened bottles of Diocto Liquid from Stanford Kids’s Well being on Aug. 2, 2017, then eight unopened and two opened bottles of the laxative from Johns Hopkins on Aug. 3, 2017. Every bottle was from lot No. 20351701, the distribution of which Figueroa hid from the FDA.
In the meantime, PharmaTech issued a recall of Diocto Liquid and Diocto Syrup on Aug. 3.
READ MORE: These laxatives may be contaminated with life-threatening bugs
Along with testing constructive for B. cepacia, samples from the bottles examined as having complete erobit microbial counts and complete yeast and mildew counts above acceptable limits.
The FDA suggested avoiding liquid drug merchandise made by PharmaTech. On Aug. 14, three drug corporations issued all-lots, wholesale and retail stage recollects of twenty-two over-the-counter medicine made by PharmaTech.
READ MORE: All liquid medicine made by Davie firm recalled as FDA advises to not use them
This story was initially printed September 6, 2022 5:41 AM.