FDA Uncovers Possible Safety Issues at Hayward Drugmaker
Inspections carried out at a Hayward, California-based drug manufacturer have uncovered a host of potential safety issues, and the issues could end up delaying the approval of drugs from the facility. The plant in question is Imbax Laboratories, and some of the issues were present when the FDA conducted an inspection way back in 2011. One drug, Rytary, already had its approval denied by the FDA a couple months ago, and indeed, issues with the manufacturing of that drug were uncovered by the FDA during the latest round of inspections. The FDA found that the equipment used to gather testing data from Rytary was not itself adequately tested. They also discovered deficiencies with the way the company cleaned the plant, and humidity was not adequately managed in certain areas.
For more about the inspections, click here.