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LC Medical Concepts’ sterilization operations were not adequately validated to demonstrate sterility of its wound therapy kits, an Oct. 16-23, 2018, FDA inspection of the devicemaker’s Rochester, New York, facility revealed. Read More
Failure to document numerous activities including validation, corrective and preventive actions, process changes and others landed Hyperbaric Technologies a Form 483 following a Sept. 19-26, 2018, inspection of its Amsterdam, New York, manufacturing facility. Read More
The FDA expressed concerns about their clinical validity, noting that it was “unaware of data establishing the relationships between the genotypes assessed…and assertions regarding drug response for multiple drugs. Read More
The agency said that its investigators should make every effort to discuss their observations with facility management “to minimize errors and misunderstandings.” Read More
Cincinnati, Ohio-based Full Range Rehab failed to file Medical Device Reports within 30 days of receiving information that one of its devices may have caused or contributed to a serious injury, according to a 483 issued to the firm following a Jan. 30-31 inspection. Read More
Contract device manufacturer Valtronic netted a Form 483 for inadequate CAPA procedures, nonconforming products and a failure to document validations at its Solon, Ohio plant. Read More