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
A federal district judge shut down drugmaker Stratus Pharmaceuticals in Florida and distributor Sonar Products of New Jersey with a permanent injunction Thursday. Read More
The FDA issued a Form 483 to Curbell Medical Products, citing inadequate procedures for nonconforming products and corrective/preventive actions. Read More
Device manufacturer Carestream Health received a Form 483 from the FDA due to issues with its testing, validation and complaint procedures. Read More
FDA investigators said Ranier’s did not receive valid prescriptions for individuallyidentified patients for a portion of the products. Read More
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