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Observations cited in a Form 483 need to be carefully reviewed, because they represent — at least in the mind of that investigator — conditions that could make a drug adulterated. Read More
The European Medicines Agency conducted 350 good manufacturing practices inspections in the first half of this year — roughly 50 percent more than in the same period a year ago, a new report shows. Read More
The FDA hit another Indian active pharmaceutical ingredients maker with a warning letter after an inspection revealed data integrity issues and significant cGMP violations. Read More
Responding to more than a dozen Form 483 responses from compounders that say they’re not subject to FDA GMP requirements, the agency put compounders on notice outlining enforcement penalties and bulk substance rules that compounders must adhere to. Read More
The FDA is trying to reassure drug companies by making it clear that the agency won’t use its quality metrics collection to spur 483s, warning letters and other enforcement actions. Read More
An Alabama compounder is recalling all of its nonexpired drug products over possible contamination issues and stopped production of sterile compounds after the FDA received reports of adverse events. Read More
Impax Laboratories says the FDA has inspected its Hayward, Calif. manufacturing plant and cleared it of all issues raised in a 2011 warning letter, paving the way for the launch of new drug products. Read More
Cardinal Health received an FDA Form 483 for failing to investigate batch failures for a positron emission tomography drug, incomplete lab records, failure to follow SOPs and inadequate facilities to prevent contamination. Read More
Contract manufacturer Neolpharm received an FDA Form 483 at its Puerto Rican facility for quality and production failures following a June 2 to 18 inspection. Read More
A Pharmacia & Upjohn plant was slammed with its second FDA Form 483 in five years for failure to investigate discrepancies and out-of-specifications results, inadequate annual product reviews, failure to follow written procedures and inadequate documentation for cleaning procedures. Read More
The FDA handed Baxter Healthcare a six-observation FDA Form 483 for lapses in sterile process controls and failure to review batch discrepancies at its Puerto Rico manufacturing plant. Read More