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An Apotex Research facility in Bangalore, India was cited for non-compliance with GMP requirements after an inspection in November by the UK’s Medicines and Healthcare products Regulatory Agency revealed non-sterile conditions, packaging issues, and inadequate testing. Read More
The FDA issued warning letters to eight drug manufacturers for adulterated products, misbranding and unapproved drug products, among other violations. Read More
The FDA hit BODE Chemie with a Form 483 for failing to follow proper quality control procedures, in addition to other deficiencies at its facility in Hamburg, Germany. Read More
The FDA hit Amneal Pharmaceuticals with a Form 483 over cleaning, sanitation and quality control issues after an October inspection of the drugmaker’s Paterson, New Jersey facility. Read More
The FDA issued a warning letter to Prosana Distribuciones in Mexico City for serious GMP violations and for producing an adulterated drug product. Read More
The FDA hit Chinese API manufacturer Jiangsu Yongan Pharmaceuticals with a Form 483 over serious deficiencies relating to poor sanitation, record keeping and training. Read More
The FDA hit Amneal Pharmaceuticals with a Form 483 over cleaning, sanitation and quality control issues after an October inspection of the drugmaker’s Paterson, New Jersey facility. Read More