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The FDA issued a warning letter to TEI Biosciences’ for “systemic” quality failures the agency found during an Oct. 9 to Nov. 2, 2018, inspection of its Boston, Mass., facility. Read More
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