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The FDA hit drug compounder Fusion IV with a warning letter after an agency inspection found numerous problems at its outsourcing facility including the failure to meet conditions for section 503B exemptions from the agency’s drug approval requirements. Read More
Recent FDA warnings and untitled letters show the agency’s enforcement efforts for advertising and promotion are focused on product risk information and pre-approval promotions for investigational drug products, according to two Ropes and Gray attorneys. Read More
Drug manufacturer Degasa did not adequately test its products or include all necessary data in laboratory records, according to a warning letter from the FDA. Read More
Drug manufacturer Degasa did not adequately test its products or include all necessary data in laboratory records, according to a warning letter from the FDA. Read More
The FDA issued a warning letter to McCallum Manufacturing for deficiencies in process validation and quality control after an inspection of the firm’s Barnsley, South Yorkshire facility. Read More
The FDA hit Optikem with a Form 483 after the agency’s investigator observed unsanitary conditions and problems with records in an inspection of the firm’s Denver facility. Read More
In its first required inspection metrics report for 2017, FDA officials found a median time of 102 days between inspection requests by the FDA to a facility and the beginning of inspections, and a median of seven days between the beginning of a pre-approval inspection and the issuance of a Form 483. Read More
The FDA warning letter asked the company to describe its corrective action plan and testing procedures to ensure all product batches are tested for identity and strength before being sent to the United States. Read More
The FDA issued a warning letter to McCallum Manufacturing for deficiencies in process validation and quality control after an inspection of the firm’s Barnsley, South Yorkshire facility. Read More