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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
The FDA issued a 14-observation Form 483 to Irvine, California drugmaker Stason Pharmaceuticals for inadequate testing and other quality failures. Read More
The FDA hit JHS Svendgaard Hygiene Products with a warning letter for serious GMP failures at its drug manufacturing facility in Himachal Pradesh, India. Read More
The FDA issued a warning letter to an over-the-counter drug manufacturer in New Jersey for failing to maintain its facility in a good state of repair and other serious GMP violations. Read More
The FDA issued a warning letter to over-the-counter drugmaker Essnd Global for serious GMP deficiencies at its facility in Maharashtra, India. Read More