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An Indian drug manufacturer’s facility in Salcete, Goa drew a warning letter from the FDA for serious violations, including inadequate cleaning that left drug product residues inside manufacturing equipment. Read More
The FDA hit Blaine Labs with a lengthy Form 483 for a host of violations at its Santa Fe Springs, CA, facility, including repeated quality unit failures. Read More
The facility lacked written procedures for stability studies, deviation investigations, out-of-specification investigations and product release. Read More
The FDA issued a warning letter to an active pharmaceutical ingredient and over-the-counter drug manufacturer in the Chinese port city of Guangzhou for releasing products without performing microbial tests. Read More