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The FDA hit California drugmaker Blaine Labs with a warning letter for serious violations at its Santa Fe Springs facility, including the failure to investigate out-of-specification (OOS) test results. Read More
European officials cited Indian API maker Dishman Carbogen Amcis for serous quality failures found during an inspection of its facility in Gujarat. Read More
An FDA investigator found lapses in good manufacturing practices in an inspection of Time-Cap Laboratories’ drug manufacturing and repackaging facility in Farmingdale, New York. Read More
The FDA is working with the Centers for Disease Control and Prevention (CDC) to determine how it will restart routine on-site inspections of drug manufacturing facilities, the agency has announced. Read More
FDA investigators found numerous GMP lapses at Innoveix Pharmaceuticals’ facility in Addison, Texas, including empty syringes, vials, gloves, and other materials left in a biosafety cabinet overnight. Read More
The FDA hit online pharmacy Unitedpharmacies.md with a warning letter for marketing on its website unapproved and misbranded products as COVID-19 treatments. Read More
Pfizer was taken to task in an FDA warning letter over testing violations at its Visakhapatnam, Andhra Pradesh sterile injectable drug facility. Read More