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A Virginia maker of implants used in plastic surgery was slapped with a warning letter after an FDA inspection found flaws with the company’s validation and MDR reporting practices. Read More
Inspectors from the FDA’s Florida district office found a pattern of missing or faulty records of supplier audits at a Clearwater, Fla.-based Soft Computer Consultants, leading to an eight-observation Form 483 for the company. The company also received a Warning Letter from the FD Read More