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Drugmakers have just over a year to comply with new Canadian regulations requiring evidence of GMP compliance at foreign facilities that make active pharmaceutical ingredients. Read More
The FDA cited Novartis’ Vaccines and Diagnostics facility in Liverpool, UK, for lapses in its equipment cleaning and validation processes and inadequate investigations and CAPAs in a Form 483 issued June 11. 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
The European Commission released new rules clarifying the responsibilities of qualified persons overseeing global, multisite manufacturing operations and the data they need to collect. Read More
The FDA issued a warning letter to Coram Healthcare over its Crownpoint, Ind., facility for serious deficiencies in producing sterile drug products. Read More
Merck is recalling thousands of bottles of Temodar and temozolomide capsules because cracks in the caps have rendered the child-resistant closure ineffective. 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