The FDA handed Defender SD Manufacturing a five-observation Form 483 following an inspection of its San Diego, Calif., facility for a quality unit that lacked authority to investigate errors, lack of written production procedures and environmental monitoring deficiencies, among other lapses. Read More

The FDA handed Advanced Accelerator Applications a five-observation Form 483 after conducting an inspection of its Millburn, N.J., facility for failure to establish written procedures for production and process controls for its drug products, and other lapses. Read More

The FDA has told Fullerton, Calif.-based Synovo Production to cease manufacture of its hip cup replacement system because the company failed to notify the agency about significant changes to the product. Read More