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Miyoshi America didn’t investigate associated lots that may have been linked with specific drug product lot failures, among other lapses observed by FDA investigators during a recent inspection of the company’s Dayville, Conn., facility. Read More
Spartan Chemical didn’t conduct validation studies for the water system used to manufacture drug products, among other quality lapses observed during a recent FDA inspection of the company’s Maumee, Ohio facility. Read More
Teva Pharmaceutical 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
The FDA issued warning letters to four drug manufacturing plants for failure to maintain good manufacturing practices — and to one firm for producing misbranded and unapproved drug products. Read More
The FDA has hit Sircle Laboratories with a warning letter over lapses in current good manufacturing practices, including its choice of contract manufacturers, following a recent inspection of the company’s Ridgeland, Miss., plant. Read More
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