FDA warns Integra ’ s TEI Biosciences over quality, validation issues

The FDA recently revealed a warning letter it sent to Integra LifeSciences‘ (NSDQ:IART) TEI Biosciences over four noted violations it found during an inspection of TEI’s Boston-based facilities. The federal watchdog said that it inspected the company’s facilities where it produces collagen-based medical devices, including its Xenform soft tissue repair matrix, from last October to November last year. The recently released letter covers both the noted violations and a number of responses from the company it received from last November to February. The FDA’s first noted violation was a failure properly validate manufacturing processes that cannot be verified post-production. The agency noted two issues with the validation process for the manufacturing of the company’s extracellular bovine matrix-based devices, including its Xenform soft tissue repair matrices and a failure to demonstrate bacterial endotoxin testing of the devices. In its second violation, the federal watchdog dinged the company for failing to establish and maintain procedures to prevent contamination of its equipment or products, specifically noting issues with its water system. The FDA said that the company did not provide data showing it tests the water system it uses to produce extracellular bovine matrix devices for bacterial endotoxins. The agency added that TEI personnel informed that the company does not routinely perform microbial identifications on the bioburden recovered from the water s...
Source: Mass Device - Category: Medical Devices Authors: Tags: Featured Food & Drug Administration (FDA) Regulatory/Compliance Integra LifeSciences TEI Biosciences Source Type: news