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The FDA cited sterile drugmaker Nanobots Healthcare in Houston, Texas in a lengthy Form 483 for deficiencies with testing, sterility, certification and equipment calibration. Read More
The FDA hit Pennsauken, New Jersey drugmaker Cetylite Industries with a Form 483 for multiple GMP failures and the lack of annual product reviews. Read More
The FDA hit a Farmingdale, New York generic drugmaker with a Form 483 for a large number of violations, including inadequate complaint investigations and multiple issues with testing. Read More
Pharma giant Pfizer was taken to task in an FDA warning letter over testing violations at its Visakhapatnam, Andhra Pradesh sterile injectable drug facility. Read More
The FDA hit a drug compounder in Hallandale, Florida with a warning letter for failing to properly maintain the facility and other serious violations. Read More
A federal court has invalidated six key patents for Amarin’s potential blockbuster heart drug Vascepa, opening the door for generic competitors. Read More
The FDA issued a warning letter to an over-the-counter drug manufacturer in Hangzhou, China for serious GMP violations including inadequate testing for drug products prior to release. Read More
The FDA cited Anchen Pharmaceuticals for four violations at its manufacturing facility in Irvine, California, including particulate contamination. Read More