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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 European Commission has updated its GMP guideline on process validation to reflect the EU’s current risk-based approach to managing quality systems over the entire lifecycle of a drug. Read More
The FDA has halted imports of drugs from two Ipca manufacturing facilities in India due to good manufacturing practice violations, marking the second and third FDA-imposed import alerts against the drugmaker this year. 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 has won a consent decree against a Texas compounder barring the company, Specialty Compounding, from producing and selling sterile drugs until it fixes manufacturing quality deficiencies that led to past reports of bacterial contamination of its products. Read More