A drug manufacturer used the same, uncleaned equipment to make pesticides as it did several human drugs, according to a warning letter released by the Food and Drug Administration. The result was that at least two medicines were contaminated with pesticides, the agency noted.
The FDA’s sternly worded letter charged that drug manufacturer Product Quest MFG, LLC of Daytona Beach, Florida and its manufacturing facility, Ei LLC in Kannapolis, North Carolina, committed “significant violations.” It also noted that the firm’s response to the problems so far were “inadequate” and that its investigations into the extent of the problems were “not thorough and scientifically sound.” The agency levied legal threats if the issues weren’t fixed pronto.
“Failure to promptly correct these violations may result in legal action without further notice including, without limitation, seizure and injunction,” the letter stated. They agency also threatened to deny the manufacturer’s drug applications, contracts, and block its drug export certifications.