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The FDA issued a warning letter to Coram Healthcare over its Crownpoint, Ind., facility for serious deficiencies in producing sterile drug products. 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
Yet another Indian drugmaker has been dinged for serious data integrity and GMP issues — this time during a June 4 to 7 inspection by the World Health Organization. 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
Contract manufacturer Pernix Manufacturing received an 11-observation Form 483 for a litany of cGMP violations, including failing to investigate complaints about caterpillars and poppy seeds in vials of finished product. Read More
Seattle Genetics received a six-observation Form 483 from the FDA for documentation and adverse event reporting failures related to its only approved product — cancer drug Adcetris. Read More
Seattle Genetics received a six-observation Form 483 from the FDA for documentation and adverse event reporting failures related to its only approved product — cancer drug Adcetris. Read More