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Active pharmaceutical ingredient maker Pan Drugs was hit with an FDA warning letter and import alert after an inspection revealed significant data integrity and cGMP issues. Read More
A Pharmacia & Upjohn plant was slammed with its second FDA Form 483 in five years for GMP deficiencies ranging from quality systems, facilities and equipment to materials, production and laboratory systems. 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
GlaxoSmithKline’s Aiken, S.C., plant received a four-observation Form 483 from the FDA for failing to follow quality control procedures and other GMP violations. 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
Indian active pharmaceutical ingredient maker Pan Drugs Limited was hit with an FDA warning letter after an inspection revealed data integrity issues and significant cGMP violations, leading the company to announce it would sell its product locally. The company will stay on the FDA’s Import Alert list until it makes the corrections. 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