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The FDA slapped warning letters on two more drug outsourcing facilities for sloppy sterile processing, bringing to seven the number of compounders cited for sterile manufacturing deviations in the past six months. Read More
The FDA has handed Hospira its seventh warning letter in seven years and the second in the past six months, this time for poor sterile processing, inadequate batch failure investigations and data integrity weaknesses at its Liscate, Italy, manufacturing plant. Read More
The FDA warned a Chinese maker of active pharmaceutical ingredients over data integrity lapses and other serious deviations from current good manufacturing practice. Read More
The FDA has warned a French drugmaker for data integrity issues related to the production of active pharmaceutical ingredients at its Thailand manufacturing plant. Read More
The FDA warned Cadila Pharmaceuticals for cGMP violations that include quality controls, complaint handling and data integrity at its Gujarat, India, active pharmaceutical ingredients manufacturing plant. Read More
The FDA slapped warning letters on two more drug outsourcing facilities for sloppy sterile processing, bringing to seven the number of compounders cited for sterile manufacturing deviations in the past six months. Read More
The FDA has handed Hospira its seventh warning letter in seven years and the second in the past six months, this time for poor sterile processing, inadequate batch failure investigations and data integrity weaknesses at its Liscate, Italy, manufacturing plant. Read More