Showing Latest Articles
FDA warns novartis of violations at three plants Full Text
Pharmaceutical Technology, 12/23/2011
In a Warning Letter, FDA cited significant violations of CGMP regulations, including several repeat observations, at three Novartis facilities. The violations included failure to prevent microbiological contamination of sterile drug products, failure to investigate out–of–specification batches, failure to clean and maintain equipment, and failure to ensure drugs’ identity, strength, quality, and purity.
