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The FDA issued a warning letter to DermaPharm for serious GMP violations including inadequate testing of raw materials and finished products. Read More
Windlas Healthcare drew a warning letter from the FDA after agency investigators found serious data integrity violations at its API manufacturing facility in Uttarakhand, northern India. Read More
With the FDA’s foreign inspections on hold through April due to the coronavirus outbreak, the agency is doing “anything and everything” to make use of international regulators to keep inspections going, according to a senior CDER official. Read More
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