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FDA inspectors said the firm had not established records that described quality control procedures to monitor aluminum equivalence attenuation within its surgical C-Arm tables. Read More
The firm also failed to adequately maintain one of its device master records, as it was unable to provide the DMR specification for the chemical makeup of silicone material used in the firm’s ultra-soft silicone products. Read More
The FDA flagged six devicemakers for a variety of deficiencies including complaint handling, inadequate documentation and quality system failures. Read More
ITG-Medev failed to follow up on its promised solutions to nonconforming process validations and documentation of acceptance activities, the FDA said in a warning letter to the devicemaker. Read More
The FDA cited Richard Wolf Medical Instruments for CAPA and complaint procedures following a June 26 to July 17 inspection of the company’s Vernon Hills, Illinois facility. Read More