We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Marcus Research Laboratory drew an FDA warning letter for lapses in current good manufacturing practices observed at its St. Louis, Mo., active pharmaceutical ingredient (API) manufacturing facility. Read More
The company “relied on resampling and retesting to invalidate” OOS results for an active pharmaceutical ingredient results without identifying a root cause, the FDA said. Read More
RAAS argued that it was not obligated to submit an IND before initiating the clinical investigations because the products under study are not drugs, but the FDA disagreed. Read More
Missouri Analytical Laboratories, a contract drug testing facility, drew a warning letter from the FDA for failing to comply with good manufacturing practices. Read More
California-based RAAS Nutritionals was slapped with a Warning Letter by the FDA for conducting trials on human subjects without first submitting an investigational new drug (IND) application. Read More
Aurex Laboratories’ East Windsor, N.J., facility lacked detailed cleaning and maintenance procedures, among other quality lapses observed during an FDA inspection. Read More
Apothecus Pharmaceutical lacked proper safeguards to ensure that only authorized employees could change master production and control records, among other quality lapses observed by FDA investigators during a recent inspection of the company’s Hicksville, N.Y. facility. Read More
Contract drug manufacturer Hovione failed to properly maintain production equipment at its East Windsor, N.J., plant to prevent malfunctions from altering drug products, among other lapses, FDA investigators observed during a recent inspection. Read More
FDA investigators observed that Pine Pharmaceuticals’ outsourcing facility in Tonawanda, New York failed to properly investigate batch discrepancies, among other quality lapses, during an inspection that found repeat deficiencies seen in prior agency visits. Read More
Teva Pharmaceutical has stopped drug manufacturing at its Irvine, Calif., facility following a recent FDA inspection that revealed lapses, including possible mold contamination caused by water leaks. Read More
FDA investigators observed inadequate investigations into bacterial contamination, documentation lapses and other quality deficiencies during inspections of six drug facilities. Read More
A Las Vegas, Nev.-based drug compounder, AnazaoHealth, has received a warning letter from the FDA for marketing unapproved new drugs and for how it handles adverse event reports. Read More