The FDA warned Raritan Pharmaceuticals for violating GMP standards, noting the firm failed to properly test its products, which are meant for vulnerable populations, or to maintain good quality control practices. Read More
A June FDA inspection left a Washington state pharmacy and compounder with a Form 483 citing unsafe production practices that could lead to drug contamination. Read More
The FDA issued Form 483s to Jensen Industries, Tyson Bioresearch, OsteoSymbionics and Innovative Sterilization Techniques, citing problems with their procedures for corrective/preventive actions, complaints and MDRs. Read More
The FDA issued a 483 to the Nephron Pharmaceuticals facility in West Columbia, S.C., for inadequate sterilization process validation, insufficient laboratory controls and poor quality control. Read More
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