A warning letter launched by the Food and Drug Administration. The consequence was that a minimum of two medicines were contaminated with pesticides, the company famous.
The FDA’s sternly worded letter charged that drug producer Product Quest MFG, LLC of Daytona Beach, Florida, and its manufacturing facility, Ei LLC in Kannapolis, North Carolina, dedicated “vital violations.” It additionally famous that the agency’s response to the issues to date were “insufficient” and that its investigations into the extent of the issues were “not thorough and scientifically sound.” The company levied authorized threats if the problems weren’t fastened pronto.
“Failure to promptly appropriate these violations might consequence in authorized motion with out additional discover together with, with out limitation, seizure and injunction,” the letter said. The company additionally threatened to disclaim the producer’s drug functions, contracts, and block its drug export certifications.
Neither Product Quest nor Ei instantly responded to Ars’ request for remark.
On its web site, Product Quest notes that:
Quality will not be a aim to be achieved or a rating on a report—it’s a manner of working. It’s evident in our state-of-the-art services and power in each regulatory and buyer audit performances. It’s delivered by our company integrity and higher-than-industry requirements, which consequence in exceeding our prospects’ expectations each single day.
Likewise, Ei, which was acquired by Product Quest in 2013, stated on its web site that “in a really actual sense, high quality is our product.”
The FDA appears to disagree. It famous that Product Quest “manufactured topical human medicine and several other pesticides in the identical constructing, utilizing shared gear,” which were not adequately cleaned to stop cross-contamination. That contamination may trigger pesticides to make their manner into human medicine and for various human medicine to infect one another, the company stated.
During its investigation, the FDA discovered data indicating that two unidentified human medicine made by Product Quest had been contaminated with a pesticide, the identify of which was redacted. The medicines were manufactured on the identical gear because the pesticide. The company additionally famous situations when the drug maker failed to research different contamination points. In these circumstances, two human medicine—erythromycin pledgets, a topical antibiotic, and clobetasol propionate, a corticosteroid spray—were discovered to include “unknown impurities.” Documents advised that soiled gear was once more the trigger, however the FDA stated the drug producer didn’t do any follow-up to determine what occurred to stop it from occurring in the longer term.
“[Product Quest] continued to make use of the identical gear for business manufacturing after [it] detected the impurities, probably cross-contaminating different merchandise,” the FDA wrote.
Product Quest has 15 days from the receipt of the letter to answer the FDA.